Search Results
Phase I Clinical Trial of iPSC-Based Therapy (MyoPAXon) for Duchenne Muscular Dystrophy
This study aims to find out whether MyoPAXon, a genetically modified cellular therapy treatment, is safe to give to patients with Duchenne Muscular Dystrophy (DMD), and whether it has any positive effect on their disease. It will also determine how much MyoPAXon is safe to give to a person at one time.
• diagnosed with Duchenne muscular dystrophy (DMD) and non-ambulatory
• age 18 or older
• off investigational treatments for at least 30 days
• presence of HLA antibodies directed toward HLA antigens on MyoPAXon
• active treatment with another investigational therapy
• known allergy to MyoPAXon components
COG AALL1732: A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (IND#:133494, NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy
• patients must be > 365 days and < 25 years of age
• participant has newly diagnosed B-ALL or MPAL with ≥25% blasts on a bone marrow (BM) aspirate or newly diagnosed B-LLy
• see link to clinicaltrials.gov for complete inclusion criteria
• patients with Down syndrome are not eligible
• patients with acute undifferentiated leukemia (AUL) are not eligible
• female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential
• lactating women who plan to breastfeed their infants while on study and for 2 months after the last dose of inotuzumab ozogamicin.
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-12: A Phase 1 Study Evaluating BAFFR-targeting CAR T cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)
The purpose of this study is to assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B- cell non-Hodgkin lymphoma (B-NHL). We also will determine the maximum tolerated dose (MTD)/RP2D of BAFFR-CART cells.
• able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• diagnosis of Large B-cell lymphoma (LBCL) or Mantle Cell Lymphoma (MCL)
• cancer has recurred or not responded to at least 2 prior lines of treatment
• willing to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of medication
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• prior allogeneic stem cell transplant
• Autologous stem cell transplant within 6 months
• Auto-immune disease or condition requiring systemic immunosuppressant therapy, including uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP)
• significant cardiac disease including heart failure or arrhythmia
• history of a stroke in the past 6 months
• history of another active cancer in the past 3 years
• women who are pregnant or breast feeding
DESTINY-Endometrial01: An Open-Label, Sponsor-Blinded, Randomized, Controlled, Multicenter, Phase III Study of Trastuzumab Deruxtecan (T-DXd) Plus Rilvegostomig or Pembrolizumab vs Chemotherapy Plus Pembrolizumab as First-Line Therapy of HER2-Expressing (IHC 3+/2+), Mismatch Repair Proficient (pMMR), Primary Advanced or Recurrent Endometrial Cancer (DE-01)
The purpose of this research is to learn more about whether T-DXd with Rilvegostomig or Pembrolizumab works better and is safe for the treatment of primary advanced or recurrent endometrial cancers that express the HER2 protein in high levels and that have a genetic characteristic known as mismatch repair proficiency (pMMR), when compared to chemotherapy (Carboplatin and Paclitaxel).
• diagnosis of epithelial endometrial cancer
• HER2 positive
• advanced disease (Stage III/IV) or first recurrent endometrial cancer
• first time systemic anticancer therapy or may have received one prior line of chemotherapy with curative intent (chemotherapy or chemoradiation) if disease recurrence or progression occurred ≥ 6 months after last dose of chemotherapy
• may not be able to do strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete Inclusion criteria
• history of organ transplant
• other ongoing or active illness such as infection, serious chronic gastrointestinal conditions associated with diarrhea, active non-infectious skin disease requiring systemic treatment, heart or lung diseases
• see link to clinicaltrials.gov for complete Exclusion criteria
A randomized double-blind, placebo-controlled, multicenter trial assessing the impact of lipoprotein(a) lowering with pelacarsen (TQJ230) on the progression of calcific aortic valve stenosis [Lp(a)FRONTIERS CAVS]
The purpose of the study is to assess if the study treatment, pelacarsen, taken by people with mild or moderate CAVS and elevated lipoprotein(a) can safely help slow the progression of calcific aortic valve stenosis (CAVS). Pelacarsen is a treatment being tested that acts on a particle called Lp(a), which if elevated, may play a role in CAVS.
• men and women between the ages of 50 and 79
• diagnosis of mild or moderate calcific aortic valve stenosis
• ejection fraction (EF) less than 55%
• severe aortic or mitral valve stenosis
• uncontrolled hypertension
• history of cancer
• women who are pregnant or breast feeding
• unable to have an echocardiogram or CT scan
MT2021-08: Phase II, Open-Label, Prospective Study of T Cell Receptor Alpha/Beta Depletion (A/B TCD) Peripheral Blood Stem Cell (PBSC) Transplantation for Children and Adults with Hematological Malignancies
The research aspect of this trial is the use of a new machine to remove specific lymphocytes from the donor’s peripheral blood stem cells (PBSCs). This is called T cell receptor alpha/beta T cell depletion. This machine does such a good job at removing the unwanted donor T cells, and as a result we think patients will need fewer drugs to suppress their immune system.
• hematological cancer needing stem cell transplant
• 60 years old or younger
• pregnant or breast feeding
• active infection
• positive for HIV, Hepatitis B or C
• brain metastasis
MT2023-42: A Phase 1 Study of FT819 in B-Cell Mediated Autoimmune Diseases
This study will test the safety of FT819, an experimental cell product, in people with severe active systemic lupus erythematosus. The purpose of this study is to understand the way someone's body processes and responds to FT819, and to find out what effects FT819 may have on a person and their systemic lupus erythematosus.
• between 18 and 40 years old
• diagnosed with Systemic Lupus Erythematosus (SLE)
• failure to respond to glucocorticoids and ≥2 of the following treatments for at least 3 months: cyclophosphamide (CY), mycophenolic acid or its derivatives, belimumab, methotrexate, azathioprine, anifrolumab, rituximab, obinutuzumab, cyclosporin, tacrolimus, or voclosporin
• active neurological symptoms of SLE
• CNS disease such as stroke, epilepsy, or neurodegenerative disease in the past two years
• prior treatment with CAR T-cell therapy, allograft organ transplant, or hematopoietic stem cell transplant
HM2017-24 : Phase I/II Study of Nivolumab in Combination with Ruxolitinib in Relapsed or Refractory Classical Hodgkin Lymphoma: BTCRC-HEM-027
Participants who take part in this study will receive a study drug called ruxolitinib with a standard drug called nivolumab. The study is being done to measure the percentage of tumor (lymphoma) that shrinks after receiving ruxolitinib in combination with nivolumab. This study will also measure the length of time the lymphoma is inactive and how safe the combination is to administer to participants. Ruxolitinib is a pill that is taken twice every day. Nivolumab is given as an infusion in the clinic once every 4 weeks.
• age 18 or older
• able to walk and do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• confirmed diagnosis of classical Hodgkin lymphoma that has reoccurred or not responded to treatment
• women and men who are of child bearing age must use required birth control
• there are additional criteria for prior treatment and laboratory results (study staff will review)
• inability to swallow oral medication or any condition that affects absorption of oral medications
• women who are pregnant or breast feeding
• additional criteria about current medical history (study staff will review)
PIOGLITAZONE-METFORMIN COMBINATION TREATMENT FOR HIGH RISK ORAL PRENEOPLASIA
The purpose of this study is to learn about the safety and effects of pioglitazone and metformin on people and their risk of cancers of the head or neck. We hope to learn more about the potential for pioglitazone and metformin to be used as a way to prevent oral or oropharyngeal cancers in people who are at risk for those cancers. Participants will get both pioglitazone and metformin, as a single pill to be taken at the same time for 12 weeks.
• hyperplasia in high risk areas (floor of mouth, mobile tongue, oropharynx) confirmed by biopsy
• able to swallow a tablet whole
• Body mass index (BMI) is ≥ 18.5
• sexually active persons of child-bearing potential agrees to use adequate contraception
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding or planning to become pregnant
• diagnosis of Type I or Type II diabetes that is being treated with insulin or an antidiabetic agent
• history of bladder cancer, including in situ bladder cancer
• history of invasive cancer (other than non-melanoma skin cancer or cervical cancer in situ) in past 18 months
• see link to clinicaltrials.gov for complete exclusion criteria
RANDOMIZED PHASE III TRIAL OF NEOADJUVANT IMMUNOTHERAPY WITH RESPONSE-ADAPTED TREATMENT VERSUS STANDARD-OFCARE TREATMENT FOR RESECTABLE STAGE III/IV CUTANEOUS SQUAMOUS CELL CARCINOMA
We are studying the use of immunotherapy before and after (in some cases) surgery to see if it will extend the length of time until the cancer returns compared to the usual approach. The usual approach for patients who are not in a study is treatment with surgery which may be followed by radiation. Participants will either get the study drug cemiplimab (REGN2810) before surgery for the cancer or will have up-front surgery. For those who receive cemiplimab (REGN2810), it will be given before surgery every 3 weeks for up to 12 weeks. In either case, participants may also receive radiation after surgery depending on the tumor tissue results from surgery.
• diagnosis of invasive cutaneous squamous cell carcinoma (CSCC) or regional lymph node or in-transit metastasis of CSCC
• previously untreated or recurrent CSCC
• walking and able to do self-care, but unable to work; up and about at least 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
• women who are pregnant or breastfeeding
• history of solid organ or bone marrow transplant
• no active, known, or suspected autoimmune disease for the past 5 years
• current significant medical issues
• see link to clinicaltrials.gov for complete Exclusion criteria
Transcatheter Mitral Valve Replacement with the Medtronic Intrepid™ TMVR System in patients with severe symptomatic mitral regurgitation – APOLLO Trial (APOLLO)
The purpose of this study is to determine if replacing the mitral valve without open-heart surgery is as safe and effective as standard mitral valve surgery in patients with similar medical conditions. This system allows a bioprosthetic mitral valve (investigational valve) to be implanted through a long, thin, flexible tube that is inserted through an incision in the side of the chest or through an incision made in the groin area and through a vein in the leg. Participation in the study is expected to last approximately 5 years from the day the valve is implanted.
• diagnosis of moderate or severe mitral value regurgitation with symptoms
• multidisciplinary heart team thinks patient is not able to have treatment an approved transcatheter repair or conventional mitral valve procedure
• prior transcatheter mitral valve procedure with device currently implanted
• left ventricular ejection fraction <30%
HM2021-31: A Phase 1b Open-Label Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination with Other Anti-cancer Agents in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)
The purpose of this study is to evaluate if the investigational combination of drug called loncastuximab tesirine in combination with another anti-cancer agent is a safe and effective treatment for patients with relapsed or refractory B-cell Non-Hodgkin Lymphoma.
• diagnosis of relapsed (disease that has recurred following a response) or refractory (disease that failed to respond to prior therapy) B-Cell Non-Hodgkin Lymphoma (B-NHL)
• able to walk and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• previous treatment with polatuzumab vedotin, glofitamab or mosunetuzumab
• stem cell transplant within 60 days prior to start of study drug
• Human immunodeficiency virus (HIV) seropositive
• women who are pregnant or breast feeding
HM2024-36 A PHASE 3, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL OF QUIZARTINIB ADMINISTERED IN COMBINATION WITH INDUCTION AND CONSOLIDATION CHEMOTHERAPY AND ADMINISTERED AS MAINTENANCE THERAPY IN ADULT PATIENTS WITH NEWLY DIAGNOSED FLT3-ITD NEGATIVE ACUTE MYELOID LEUKEMIA (QuANTUM-WILD)
The purpose of this research is to test how well the investigational study drug, quizartinib, works in patients with AML without a FLT3-ITD mutation who have not received any prior treatment for the disease. The study will test how it works when taken with standard chemotherapy and then taken alone to prevent the disease from coming back.
• 18 to 70 years old
• newly diagnosed, primary Acute Myeloid Leukemia (AML)
• at least able to walk do selfcare but may be unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion criteria
• any other type of leukemia
• AML caused by prior chemotherapy or radiotherapy or myelodysplastic syndrome (MDS)
• prior treatment for leukemia, with some exceptions
• see link to clinicaltrials.gov for complete Exclusion criteria
An Open-Label, Pilot Clinical Trial To Test The Safety And Feasibility Of Intestinal Microbiota Transplantation In Patients Undergoing Colon Resection
We have determined that the microbes (bacteria) in the colon can play a role in causing and preventing complications of colon surgery. While the surgical bowel prep before surgery eliminates the harmful bacteria, it also eliminates the beneficial bacteria that aid wound healing. The purpose of this study is to determine if we can restore the presence of good bacteria (also known as ‘intestinal microbiota’) in the colon by transplanting them from a healthy donor.
• 18 to 75 years old
• having surgery for diverticulitis or sigmoid colon cancer
• able to provide fecal samples
• see link to clinicaltrials.gov for complete inclusion criteria
• history of inflammatory bowel disease (Crohn's, Ulcerative Colitis)
• women who are pregnant or breastfeeding
• presence of ileostomy or colostomy
• history of solid organ or bone marrow transplant -receiving cancer chemotherapy, immunotherapy, or radiation
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-08: Phase I open-label, dose escalation trial of BI 1831169 monotherapy and in combination with an anti-PD-1 mAb in patients with advanced or metastatic solid tumors.
This study tests the use of the oncolytic virus BI1831169 (VSV-GP) as an immunotherapy in patients with advanced solid tumors. This trial is the first-in-human trial to test the safety and early efficacy of BI1831169 by itself (Part 1) and in combination with the PD-1 inhibitor ezabenlimab (Part 2).
• confirmed diagnosis of an advanced, and/or metastatic or relapsed/refractory solid tumor that can not be surgically removed
• must have exhausted available treatment options or refused established treatment options
• restricted from physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for additional Inclusion criteria
• major surgery or radiation therapy in the past 4 weeks
• active hepatitis B or C infection
• severe or serious, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation (study staff will review)
• see link to clinicaltrials.gov for complete Exclusion criteria
MT2022-60: A phase II study of Pembrolizumab+ BEAM conditioning regimen before autologous stem cell transplant (ASCT) followed by pembrolizumab maintenance in patients of relapsed classic Hodgkin lymphoma
This drug study aims to estimate at initiation of treatment to the occurrence of disease progression or expiration at 1 years post autologous stem cell transplant of classical Hodgkin’s lymphoma patients treated with BEAM autologous stem cell transplant combined with pembrolizumab given pretransplant and for 1 year post-transplant maintenance.
• eligible for autologous stem cell transplant (ASCT) with BEAM conditioning regimen
• unable to do strenuous activities but can walk and perform light or sedentary tasks, such as housework or office work
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• known active central nervous system (CNS) disease
• history of or active autoimmune disease, or other syndrome that requires systemic steroids or autoimmune agents
• had an allogenic tissue/solid organ transplant
• women who are pregnant or breast feeding
MT2023-46: A Phase 3, multicenter, randomized, open-label, parallel group, treatment study to assess the efficacy and safety of the lifileucel (LN-144, autologous tumor-infiltrating lymphocytes [TIL]) regimen in combination with pembrolizumab compared with pembrolizumab monotherapy in participants with untreated, unresectable or metastatic melanoma
We want to find out whether lifileucel is safe and works in treating untreated, unresectable or metastatic melanoma. Lifileucel is a type of medicine, known as immunotherapy, that uses your body’s immune system to fight cancer. Lifileucel is also called “tumor infiltrating lymphocytes” (TIL) and is made up of specialized white blood cells known as lymphocytes or “T cells” obtained from a piece of your tumor. T cells are a part of your immune system that help your body fight against infections and diseases including fight cancer.
• 18 to 70 years old (in certain cases, people older than 70 may be able to enroll)
• diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma
• may not be able to do physically strenuous activity but walking and able to do light or sedentary work, e.g., light house work, office work
• participants of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control
• see link to clinicaltrials.gov for complete Inclusion criteria
• melanoma of uveal/ocular (eye) origin
• symptomatic untreated brain metastases
• had another cancer in the previous 3 years
• history of allogeneic cell or organ transplant
• see link to clinicaltrials.gov for complete exclusion criteria
A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
This research study is testing a potential new treatment for pulmonary hypertension (high lung blood pressure due to heart failure) called TX000045 (study drug). Participants will be assigned to a study group and receive active study drug or a placebo (drug with no active ingredients). The study will last approximately 9 months
• 18 Years to 83 years old
• male or female of non-childbearing potential
• diagnosis of Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)
• Chronic medication for heart failure or cardiovascular disease is at a stable dose
• see link to clinicaltrials.gov for complete Inclusion criteria
• started a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study
• history or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular disease liver disease, infectious disease, or malignancy
• women who are pregnant or breastfeeding
• see link to clinicaltrials.gov for complete Exclusion criteria
A Prospective, Multi-Center, Open Label, Randomized Control Clinical Trial Evaluating the Safety and Efficacy of the Cordella™ Pulmonary Artery Sensor System in New York Heart Association (NYHA) Class II Heart Failure Patients (PROACTIVE- HF-2 Trial)
The Cordella™ Pulmonary Artery Sensor System is a possible treatment for New York Heart Association (NYHA) Class II and III heart failure. The main purpose of this study is to investigate the safety and effectiveness of the study device in helping to reduce Heart Failure hospitalizations.
• Heart Failure NYHA Class II or Class III
• ACC/AHA Stage D refractory Heart Failure (HF)
• history of multiple pulmonary embolism (PE)
• resting systolic blood pressure less than 90 mmHg
A Phase 3, open-label, randomized 2-arm study comparing the clinical efficacy and safety of niraparib with temozolomide in adult participants with newly-diagnosed, MGMT unmethylated glioblastoma
This study compares treatment with niraparib to temozolomide in adult participants who have newly-diagnosed, MGMT unmethylated glioblastoma.
• newly-diagnosed intracranial Glioblastoma (GBM)
• unmethylated MGMT promoter
• no prior treatment for GBM (including brachytherapy or BCNU wafers), other than surgical resection or biopsy
• not pregnant, planning to get pregnant, or breastfeeding
• for participants of child bearing age, highly effective birth control is required
• normal blood pressure (BP) or adequately treated and controlled hypertension (defined as systolic BP ≤140 mmHg and diastolic BP ≤90 mmHg)
• able to swallow oral medications whole
• see link to clinicaltrials.gov for complete Inclusion criteria
• metastatic or predominant leptomeningeal disease
• Current active pneumonitis or any history of pneumonitis requiring steroids (any dose) or immunomodulatory treatment within 90 days of planned start of the study
• gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels
• cirrhosis or current unstable liver or biliary disease
• see link to clinicaltrials.gov for complete Exclusion criteria
A phase 1a/b study to evaluate the safety and efficacy of OPB-101, an autologous mesothelin (MSLN) CAR T cell therapy with antigen-dependent expression of OUTSMART designed IL-2 cytokine in platinum-resistant ovarian cancer
This study will enroll patients with ovarian cancer who have experienced their cancer worsening after at least two previous treatments. This study will give these patients OPB-101, a genetically engineered CAR-T cell therapy product - a product that will be created from the patient's own T-cells - that the researchers hope has been designed to more accurately recognize and destroy the cancer cells. The goal of this study is to make sure OPB-101 is safe to give, if it is effective against this type of cancer, and to find the best dose of OPB-101 to give patients.
• confirmed diagnosis of high grade serous epithelial ovarian, peritoneal, or fallopian tube cancer
• recurrent platinum-resistant disease, cancer has recurred within 6 months of the last dose of platinum-based chemotherapy
• received at least 2 but no more than 3 prior lines of systemic chemotherapy including a platinum based chemotherapy
• may not be able to do strenuous activity but able to walk and do work of a light or sedentary nature, e.g., light house work, office work
• women childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 12 months after the last dose of therapy
• see link to clinicaltrials.gov for complete inclusion criteria
• women who are pregnant or breastfeeding
• uncontrolled bacterial, fungal, or viral infections
• active invasive cancer other than the cancer under study
• significant lung disease
• active central nervous system (CNS) involvement
• dependent on intravenous hydration or total parenteral nutrition
• see link to clinicaltrials.gov for complete exclusion criteria
MT2024-05: A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 cell infusion in subjects with hematological malignancies undergoing HLA-mismatched related or unrelated hematopoietic stem cell transplantation (HSCT)
This study will enroll patients with a blood cancer who need to undergo a stem cell (bone marrow) transplant using a donor that is not a full DNA match with them. It tests TRX103, a cellular therapy, to see if it is an effective and safe way to prevent Graft versus Host Disease (GvHD), a common and potentially serious side effect of stem cell transplant.
• undergoing mismatched related (haploidentical) or unrelated allogeneic hematopoietic stem cell transplantation (HSCT)
• diagnosis of one of the following hematologic malignancies: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS), or Chronic myelomonocytic leukemia (CMML)
• weight is at least 35 kgs (77 pounds)
• available mismatched related (haploidentical) or unrelated donors for peripheral blood stem cell (PBSC) donation
• study staff will review additional inclusion and exclusion criteria
• prior allogeneic bone marrow, peripheral blood, or cord blood HSCT
• HIV positive, positive hepatitis-B surface antigen or positive hepatitis-C antibody (unless treated)
• women who are pregnant, breast feeding or aim to become pregnant during the study period
MT2022-27: TRANSPIRE: Lung Injury in a Longitudinal Cohort of Pediatric HSCT Patients
People planning to undergo a bone marrow transplant and are at risk for developing problems with the lungs related to this planned therapy. The types and seriousness of lung problems that may develop after transplant can be very different and currently, we don’t exactly know what risk factors influence who develops them or how they may respond to therapy. Also, we do not know what the best test is to monitor lung function after transplant, especially in children and young adults. The purpose of this study is to help investigators learn more about lung problems after bone marrow transplant including what is the best method for diagnosing lung problems and following how well the lungs are working. In this study, clinical information, laboratory results and imaging findings will be collected from medical records to assist researchers in learning more about lung complications after bone marrow transplant.
• up to 24 years old
• undergoing allogeneic or autologous HSCT
MT2017-17:T Cell receptor Alpha/Beta T Cell Depleted Hematopoietic Cell Transplantation in patients with Inherited Bone Marrow Failure (BMF) Disorders
The purpose of this study is to learn if removing the donor T cells from the donor product using this new method will be a better way to reduce the risk of GVHD. The benefit of removing these cells with this new method is that they will prevent GVHD without requiring drugs to suppress the immune system. Potentially, the immune system will recover from the transplant faster, which in turn will also lessen the risk of severe infections. As well, the patient will not have the other common undesired side effects of these immunosuppressive drugs.
• up to 65 years of age
• have a diagnosis of Fanconi anemia
• have a suitable donor for peripheral blood cells
• women of childbearing potential and men with partners of child-bearing potential must agree to use of contraception for the duration of treatment and 4 months after the transplant
• see link to clinicaltrials.gov for additional criteria
• women who are pregnant or breastfeeding
• cancer within previous 2 years
MT2024-19: Registry and Biological Specimen Repository for Inherited Disorders with High Risk for Squamous Cell Carcinoma Development
This study is for people who have Epidermolysis Bullosa (EB), Fanconi Anemia (FA) or a bone marrow failure disorder that puts them at a higher risk of developing a form of skin cancer called squamous cell carcinoma (SCC). To learn more about these disorders and their relationship to cancer, researchers are collecting skin and blood samples to study in the lab. Blood and skin donated to the will be used by researchers at the University of Minnesota in studying the causes, diagnosis, prevention, and treatment of these disorders. We expect that this study will take about two hours, or the amount of time it takes to check in for a clinic visit and collect the specimens.
• at least 2 years of age
• inherited disorders that have an increased risk for squamous cell carcinoma (SCC) development, including, but not limited to, epidermolysis bullosa (EB), Fanconi anemia (FA), and telomere biology disorders/dyskeratosis congenita (TBD/DC)
• women who are pregnant
• people who are a ward of the state
• a prisoner
• an employee, student or trainee of the researcher
A Phase 1b/2a Double Blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Efficacy of CNP-103 in Participants Ages 12-35 with Recent Onsetn Stage 3 Type 1 Diabetes
The main purpose of this study is to see how safe and tolerable CNP-103 is for people with type 1 diabetes. CNP-103 is a nanoparticle (a tiny particle) containing special beta cell proteins. In each group of adults and teens, participants will be assigned by chance (like flipping a coin) to receive either CNP-103 or placebo (like CNP-103 but contains salt water). Participants will have a 66% chance of receiving CNP-103 and a 33% chance of receiving placebo. The total duration of participation from the first Screening visit until the last assessment is approximately 208 days.
• 12 to 35 years old
• women who are not pregnant or breastfeeding
• diagnosis of Type 1 Diabetes (T1D) within 180 days prior to study enrollment
• if on any medication used to treat the symptoms of T1D (e.g., corticosteroids), must be on a stable dose for at least 1 month before starting the study
• see link to clinicaltrials.gov for complete Inclusion criteria
• diabetic ketoacidosis (DKA) at the time of diagnosis of T1D
• see link to clinicaltrials.gov for specific criteria related to the previous use of certain drugs
MT2025-26: A LONG-TERM FOLLOW-UP STUDY IN PATIENTS WITH HEMOGLOBINOPATHY WHO RECEIVED AUTOLOGOUS CD34+ EDITED HEMATOPOIETIC STEM CELLS
To evaluate the long-term safety of BEAM-101 up to 15 years after treatment.
• received BEAM-101 in Study BTX-AUT-001 and are in the process of completing the last visit for the study
NRG-GY026: A Phase II/III Study of Paclitaxel/Carboplatin Alone or Combined with either Trastuzumab and Hyaluronidase-Oysk (Herceptin Hylecta) or Pertuzumab, Trastuzumab, and Hyaluronidase-Zzxf (Phesgo) in HER2 Positive, Stage I-IV Endometrial Serous Carcinoma or Carcinosarcoma
We are doing this study to see if we can lower the chance of endometrial cancer coming back and causing death by adding a drug or drugs that target HER2 proteins in addition to the usual combination of chemotherapy drugs. We want to find out if this approach is better or worse than the usual approach for your endometrial cancer. The usual approach is defined as care most people get for endometrial cancer, which in this case would be chemotherapy.
• HER2 positive endometrial cancer
• Stage I, II, II or IV endometrial serous or carcinosarcoma
• have not had chemotherapy for treatment of this cancer
• pelvic radiation therapy used to treat the tumor
• history of serious heart or lung disease
• plan for hysterectomy after chemotherapy
Assessment of Breast and Nipple Sensation Following Nerve Grafting in DIEP Flap Breast Reconstruction: A Prospective Study Using Two-Point Discrimination and Semmes-Weinstein Monofilaments
This study is about quality of life and physical sensation in the nipple-areola area of people who have undergone deep inferior epigastric perforator (DIEP) flap breast reconstruction with or without nerve grafting. At the post-operative clinic visits at 3, 6, 12, and 18-months post-op, participants will have sensory assessments and be asked to complete a series of questionnaires.
• 18-90 years of age
• assigned gender of female at birth
• having a DIEP flap breast reconstruction with nerve grafting of one or both breasts
• peripheral neuropathy or sensory deficits
• having an alternative reconstruction technique or a revision
MT2023-51 A Phase 2 Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Metastatic Non-Small-Cell Lung Cancer
This study is being done to learn more about the efficacy and safety of LN-145 in participants with metastatic stage IV non-small cell lung cancer.
• confirmed diagnosis of metastatic Stage IV NSCLC without specific genomic alterations
• if the tumor has a treatable mutation(s) (other than EGFR, ALK, or ROS1 genomic alterations), 1 additional line of therapy with the appropriate targeted therapy is required
• may be restricted from strenuous activity but walking and able to carry out work of a light or sedentary nature, e.g., light house work, office work
• patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of highly effective birth control during treatment and up to 12 months after all protocol-related therapy
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• on systemic steroid therapy ≥ 10 mg/day of prednisone or equivalent
• have any form of primary immunodeficiency
• had another primary cancer within the previous 3 years