Search Results
MT2023-42: A Phase 1 Study of FT819 in Participants With Moderate to Severe Active Systemic Lupus Erythematosus
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
Investigating the Effects of VNS on Central Autonomic Network and Interoception
This study is being done to find out if vagus nerve stimulation (VNS) affects how different parts of the brain interact with each other and process information. Participants must be in the REVEAL study and have a new VNS device implanted for treatment of depression. The study will last for about 19 weeks after the VNS is implanted.
• enrolled in a health insurance plan that will cover the costs associated with standard health care services and injuries
• diagnosis of chronic (at least 2 years) or 4 or more recurrent depressive episodes
• VNS therapy recommended for treatment
• has not had an adequate response to four or more adequate antidepressant treatments
• enrolled in the REVEAL CSP or REVEAL AP3 research studies
• had a prior implantable stimulation device
• currently uses or is expected during the study to use short-wave diathermy, microwave, diathermy, or therapeutic ultrasound diathermy
• acutely suicidal or made a suicide attempt within the previous 6 months
• additional mental health diagnosis other than depression (study staff will review)
• not able or willing to use their dominant arm, or upper arm circumference is greater than 50 cm
• do not speak English
• women who are pregnant
A Phase 1, First in Human, Dose-Escalation Study of TORL-1-23 in Participants with Advanced Cancer (TRIO049)
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer.
• advanced solid tumor
• restricted strenuous physical activity but can walk and able to carry light work e.g., light house work, office work
• progressive or symptomatic brain metastases
• serious, uncontrolled medical disorder or active, uncontrolled infection
• history of significant hear disease
• history of another cancer within 3 years
• women who are pregnant or breast feeding
• contact study staff for additional exclusion criteria
MT2023-28: A Phase 1 Basket Study Evaluating the Safety and Feasibility of T-Plex, Autologous Customized T Cell Receptor-Engineered T Cells Targeting Multiple Peptide/HLA Antigens in Participants with Antigen-positive Locally Advanced (Unresectable) or Metastatic Solid Tumors: PLEXI-T(TM)
This study aims to find out if investigational new drugs, TSC-204-A0201, TSC-204- A0702 and TSC-200-A0201, can help your cancer better than the standard of care (SOC) that are currently available and accepted by medical experts as a proper treatment. T-cells are part of the immune system and develop from stem cells in the bone marrow. They help protect the body from infection and fight cancer. For this study, T-cells will be collected through a process called leukapheresis. T-cells from your leukapheresis will be used to make the study drugs specifically tailored for you and your immune system. The purpose of the study is to learn if the study drugs are safe and effective in treating your type of cancer.
• previously received at least one line of standard systemic therapy for advanced or metastatic cancer and have either progressed, recurred, or were intolerant to the previous treatment
• unable to do physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• women must not be pregnant or breastfeeding
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• known active CNS metastases
• systemic steroid therapy
• history of a bleeding disorder
• active, uncontrolled bacterial, fungal, or viral infection
• prior history or have another cancer
HM2023-11 PH I study of ven/aza or ven in combination with ziftomenib (KO-539) or 7+3 induction chemo with ziftomenib for AML pts
There are certain genetic changes in the leukemia cell thought to drive the disease in patients with acute myeloid leukemia. Ziftomenib is an investigational drug that blocks the menin pathway in hopes of preventing or slowing the leukemia cells from growing and dividing. The purpose of this study is to determine the safe dose of an investigational new drug (ziftomenib) used in combination with other study drugs i.e., venetoclax and azacitidine, to treat cancer. This will include an evaluation of side effects associated with ziftomenib in combination with the other study drugs and how ziftomenib works in combination with the other study drugs (venetoclax and azacitidine).
• newly diagnosed or relapsed/refractory Acute Myeloid Leukemia (AML) with specific mutation (study staff will review)
• 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
• adequate liver, renal, and cardiac function
• women and men of child bearing age must follow specific requirements for birth control
• other types of leukemia
• active involvement of central nervous system
• clinically active human immunodeficiency virus, active hepatitis B or active hepatitis C infection
• women who are pregnant or breast feeding
• additional criteria (study staff will review)
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
• additional inclusion criteria (study staff will review)
• 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)
NEPTUNE: The Nephrotic Syndrome Study Network - RDCRN Protocol 6801 (NEPTUNE)
Nephrotic syndrome is a condition which affects the kidneys causing them to leak protein from the blood into the urine. Nephrotic syndrome is a disease that can improve (remission) and worsen (relapse) at different times throughout childhood. By collecting health information and laboratory samples, our goal is to learn more about these kidney diseases and find better ways to prevent and treat people with nephrotic syndrome. New knowledge will be shared with researchers and the public.
• Group A: up to 80 years of age with clinical diagnosis for FSGS/MCD or MN or pediatric participants who have protein in the urine and are scheduled for a kidney biopsy
• Group B: are less than 19 years old, have started immunosuppression drugs less than 30 days ago and have abnormal kidney lab values
• prior solid organ transplant
• clinical diagnosis of glomerulopathy without diagnostic renal biopsy
• systemic lupus erythematosus (SLE)
• clinical evidence of other renal diseases
Geniculate Artery Embolization
Osteoarthritis (OA) is a leading cause of disability and chronic pain that reduces physical activity and daily activities. In this clinical research study, the goal is to learn more about geniculate artery (located in the knee) embolization (GAE) treatment to see if it will reduce pain as well as stiffness and difficulty performing daily activities caused by knee OA and if it can be performed safely.
• osteoarthritis of the one knee with symptoms that have not improved after at least 3 months of treatment such as PT, injection, medications,
• partial knee replacement and total knee arthroplasty are not currently options (may be in the future)
• 40-70 years of age
• weight greater than 250 pounds
• smoke or have smoked tobacco regularly (smoking 1 or more tobacco product(s) per week) within the last year
• diabetic with A1C greater than 9%
• advanced peripheral arterial disease
MT2024-06: Phase 1/2 Study of Donor-Derived Anti-CD33 Chimeric Antigen Receptor Expressing T Cells (VCAR33) in Patients with Relapsed or Refractory Acute Myeloid Leukemia After Allogeneic Hematopoietic Cell Transplantation
To determine the safety and maximum tolerated dose (MTD) of VCAR33 in patients with relapsed or refractory acute myeloid leukemia (R/R AML) after allogeneic hematopoietic cell transplantation (alloHCT)
• at least 18 years old
• relapsed following hematopoietic cell transplant (HCT)
• unable to do strenuous activity but able to walk and able to carry out work of a light or sedentary nature, such as light house work, office work
• Original alloHCT donor is available and willing to undergo apheresis
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
• patients who have undergone more than one alloHCT
• ongoing active acute or chronic Graft vs Host Disease (GVHD) and are taking systemic immunosuppressive agents
• active CNS disease
• active or uncontrolled viral, bacterial, or fungal infection
• history of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, or breast) unless disease free for at least 3 years after the last definitive therapy
• women who are pregnant or breast feeding
A phase III, single-arm study to evaluate the efficacy and safety of ONCOFID-P-B (paclitaxel-hyaluronic acid conjugate) administered intravesically to patients with BCG- unresponsive Carcinoma in Situ of the bladder with or without Ta-T1 papillary disease
The purpose of this study is to understand if the study medication ONCOFID-P-B is effective and safe in treating patients with carcinoma in situ of the bladder who have not received benefit from standard BCG treatment and are not candidates for radical cystectomy.
• persistent or recurrent confirmed carcinoma in situ (CIS) of the bladder
• unresponsive to BCG treatment and refuse radical cystectomy or are not clinically suitable for cystectomy
• 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
• women and men of child bearing age must follow specific requirements for birth control
• current or previous muscle-invasive cancer or metastatic urothelial cancer
• current or prior systemic therapy for bladder cancer.
• women who are pregnant or breast feeding
• additional medical or mental health diagnosis (study staff will review)
Prophylactic Antibiotic Use to Prevent Urinary Tract Infection Following Radical Cystectomy and Urinary Diversion: Randomized Clinical Trial
This research is being done to determine whether not taking oral prophylactic antibiotics after surgery is less effective compared to taking oral prophylactic antibiotics after surgery in preventing urinary tract infections (UTI) within 90 days after surgery. We will divide study participants randomly (similar to tossing a coin) into two groups; one group not receiving postoperative prophylactic antibiotics and the other group receiving prophylactic antibiotics postoperatively. Both groups will receive the exact same preparation before surgery, care during the day of surgery care, postoperative care, and care after hospital discharge.
• muscle invasive bladder cancer and planning to undergo radical cystectomy with urinary diversion
• at least 18 years old
• currently receiving antibiotics for an active infection
• poor renal function
• allergic to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin)
• women who are pregnant
MT2024-07:A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Subjects with Active Systemic Lupus Erythematosus (RESET-SLE)
The purpose of this study is to find out what dose of CABA-201 can be safely administered to patients with SLE, including those with lupus nephritis (LN). SLE is thought to involve B cells that cause the body to attack different tissues in the body including your skin, joints, kidneys, heart, lungs, brain, and blood cells. LN is a type of kidney disease caused by SLE. CABA-201 is a chimeric antigen receptor T cell (CAR T) therapy. In this study, we will take some of your T cells, a type of white blood cell, and genetically modify them (put in a “code”) so that they may find and remove the B cells in your body, including the B cells that are involved in causing your disease. Once your cells are modified, CABA-201 cells will be re-infused into your body intravenously (through the vein).
• 18 to 65 years old
• diagnosis of Systemic Lupus Erythematosus (SLE)
• positive antinuclear antibody (ANA) titer or anti-dsDNA antibody
• active infection requiring medical intervention
• presence of kidney disease other than active lupus nephritis
• prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
• additional medical conditions (study staff will review)
Minnesota KPMP CKD and Resilient Diabetes Recruiting Site (KPMP)
The Kidney Precision Medicine Project (KPMP) is a research study. Our goal is learn more about kidney injury and kidney disease. By studying your kidneys, we may learn more about why chronic kidney disease happens and how to treat it more effectively or even how to prevent it. Or participants have had diabetes for many years and have not clinical signs of chronic kidney disease. By studying your kidneys, we may learn more about the factors that help protect you from kidney disease. KPMP will last for at least 10 years.
• at least 18 years old
• diagnosis acute or chronic kidney (renal) disease with diabetes mellitus (type 1 or 2) OR associated with hypertension
• persistent kidney damage based on specific lab values at least 3 months apart (study staff will review)
• Body Mass Index (BMI) greater than 40 kg/m2
• any allergic reaction to iodinated contrast
• receiving chemotherapy or radiation to treat cancer
• transplant recipient (includes solid transplant and bone marrow)
• unwilling to receive blood transfusion (if needed)
• women who are pregnant
MT2020-28: Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids for Treatment of Minnesota High-Risk Acute GVHD (aGVHD): A Phase I/II Study
The purpose of this study is to learn whether the use of Pregnyl with the drug ruxolitinib is able to reduce the need for high dose steroids to treat severe acute Graft versus Host Disease (GVHD).
• Hematopoietic Cell Transplant (HCT) recipients over 12 years of age within the first 7 days of initial treatment of high-risk Acute-graft-versus-host Disease (aGVHD)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• progressive cancer
• uncontrolled bacterial, fungal, parasitic, or viral infection
• current thromboembolic disease requiring full-dose anticoagulation
• active or recent (within prior 3 months) thrombus, irrespective of anticoagulation status
• pregnancy
• women or men of childbearing potential unwilling to take adequate precautions to avoid unintended pregnancy from the start of protocol treatment through 30 days after the last treatment
MT2023-05: GTB-3650 (anti-CD16/IL-15/anti-CD33) Tri-Specific Killer Engager (TriKE®) for the Treatment of High Risk Myelodysplastic Syndromes (MDS) and Refractory/Relapsed Acute Myeloid Leukemia (AML)
The primary purpose of this study is to identify a safe dose of GTB-3650. The study also provides preliminary disease response information for larger future studies. GTB-3650 is designed to target CD33 on leukemia/MDS cells. Cancer cells must overexpress CD33 (also referred to as CD33+), a marker found in some blood/bone marrow cancers. Based on similar studies and lab studies, it is felt there is a chance of benefit from the study treatment but the duration of benefit is unknown.
• at least 18 years old
• diagnosis of refractory or relapsed myeloid cancer
• not a candidate for potentially curative therapy, including hematopoietic stem cell transplantation, and are refractory to, intolerant of, or ineligible for therapy options that are usually given for treatment
• sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the last dose of study drug
• for the Dose Finding Component Only: must agree to stay within a 60 minute drive of the Study Center through the last study visit after the first dose (29 days)
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• women who are pregnant or breast feeding
• candidate for hematopoietic stem cell transplant (HSCT)
• known history of HIV
• active Hepatitis B or Hepatitis C
• known autoimmune disease requiring active treatment
Intraperitoneal FT536 in Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
FT536 is a type of cell product made up of “natural killer” or NK cells. NK cells are a type of immune blood cell that are known to attack cancer cells. FT536 is produced by growing cells that come from a healthy human donor. The primary purpose of this study is to identify a safe dose of FT536 cells when given alone (monotherapy).
• epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer that has recurred after treatment (no limit to the maximum number of prior treatments)
• must have received prior bevacizumab
• if there is a BRCA mutation, must have received a prior PARP inhibitor
• agree to the have an intraperitoneal catheter placed before the 1st dose of study drug
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• women who are pregnant, breastfeeding or planning to become pregnant in the next 6 months
• active autoimmune disease requiring systemic immunosuppressive therapy
• history of severe asthma and currently on chronic medications (more than inhalers)
• received enoblituzumab
• CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or needing medications for these conditions in the past 2 years
Effects of tobacco and nicotine cessation on biomarkers
This study will bank biological samples (cells from mouth, urine, blood, saliva) to investigate the effects of quitting smoking or vaping on different markers in the body.
• 21 years of age or older
• in good health
• smokes cigarettes daily
• willing to abstain from smoking for 15 days
• marijuana use
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
A Phase 1b, Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Subjects With High-risk Biochemical Recurrence of Nonmetastatic Castration-sensitive Prostate Cancer After Definitive Therapy
This study is trying a new treatment (Xaluritamig) for men whose prostate cancer returned after the first treatment, but has not spread. The objective is to determine if Xaluritamig is safe and works well without causing negative side effects seen in other treatments. Participants will get Xaluritamig through a vein in their arm over six times with doctors observing for side effects and to see how the cancer reacts.
• confirmed adenocarcinoma of the prostate
• treated by radical prostatectomy (RP) or radiotherapy (XRT) (including brachytherapy) or both with intention of cure
• PSA has doubled in 12 months or less
• normal testosterone level (greater than 150ng/dL)
• must be able to walk, carry out work of a light or sedentary nature, e.g., light house work, office work
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• prior cytotoxic chemotherapy, aminoglutethimide, ketoconazole, abiraterone acetate, or enzalutamide for prostate cancer
• prior systemic biologic therapy, including immunotherapy, for prostate cancer
• men with a female partner of childbearing potential or who are pregnant, who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 6 months after the last dose of xaluritamig
MT2023-27: A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer
This is an early study of TAK-280 for people diagnosed with a type of cancer that cannot be treated or removed by surgery and the tumor is growing or has spread during or after other standard cancer treatment.
• at least 18 years of age
• confirmed, locally advanced or metastatic cancers that can not be treated surgically
• unable to do strenuous activity but can walk and is able to do light work such as house work, office work
• history of an autoimmune disease
• major surgery or traumatic injury within 8 weeks before the first dose of the study medication
• unhealed wounds from surgery or injury
• ongoing or active infection
• contact study staff for additional requirements
VX21-522-001: A Phase 1 Multiple Dose Escalation Study Evaluating the Safety and Tolerability of VX-522 in Subjects 18 Years of Age and Older With Cystic Fibrosis and a CFTR Genotype Not Responsive to CFTR Modulator Therapy
This is a clinical research study exploring the safety and tolerability of a single dose of VX-522 for people with cystic fibrosis (CF) who are not expected to benefit from CFTR modulators.
• 18 to 65 years old
• Stable cystic fibrosis disease
• FEV1 at least 40%
• Specific CFTR gene mutations
• Uncontrolled asthma in the last year
• Oxygen saturation without oxygen therapy is >94%
• Severe liver disease
A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects with Tenosynovial Giant Cell Tumour (TANGENT)
We are conducting research on a new drug called emactuzumab. Emactuzumab is a new type of monoclonal antibody. An antibody is a protein produced by the body’s immune system to detect harmful substances. A monoclonal antibody is an artificially created protein that acts like a human antibody. Each antibody is specific for a single substance. Emactuzumab antibodies are aimed at blocking a type of protein called “CSF-1 receptors” from being able to work and to stop a tumor from growing. We will also examine how long this response will last, the impact on movement and quality of life. We will also examine whether participants need surgery during treatment with emactuzumab. In this study, we will also examine the safety of emactuzumab.
• at least 12 years old
• diagnosis of local or diffuse TGCT where surgery is not a good option
• women who are of child bearing age must agree to use a highly effective method of contraception
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• women who are pregnant or breast feeding
• medical conditions, including auto-immune, that require systemic immunosuppression
• current or chronic history of liver disease
• significant heart disease
ABATE-IP-18: A Phase 1b, Multi-center Study of IV Gallium Nitrate in Patients with Cystic Fibrosis who are Colonized with Nontuberculous Mycobacteria (The ABATE Study) (ABATE)
The purpose of this research study is to test the safety of giving two separate 5-day infusions (starting on Day 1 and again around Day 15) through a vein with a drug called gallium nitrate. Laboratory tests suggest that this drug may be able to fight Nontuberculous Mycobacteria (NTM) infections
• diagnosis of cystic fibrosis
• persistent Nontuberculous Mycobacterium lung infection (NTM)
• able to expectorate sputum
• enrolled in the CFF Patient Registry
• see link to clinicaltrials.gov for complete inclusion & exclusion criteria
• history of solid organ or hematological transplantation
• current diagnosis of osteoporosis
• women who are pregnant or breast feeding
• men and women who are unwilling to practice a medically acceptable form of contraception
PRE-I-SPY TRIAL - PRE-Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis: A Phase I/Ib platform trial (I-SPY)
This study is intended to find the safest dose of a new combination of drugs (ALX148 and T-DXd) and to start to determine how effective it is at treating advanced or metastatic breast cancer. This study is an addition to the ongoing ISPY study program.
• have HER2+ breast cancer
• cancer has spread to other organs or returned within 6 months after first treatment
• active heart or liver disease
• cancer has spread to the brain and is causing current symptoms
A Phase 1/2a Open-Label Dose-Ranging and Observer-Blind Placebo-Controlled, Safety and Immunogenicity Study of mRNA-1647 Cytomegalovirus Vaccine in Female and Male Participants 9 to 15 Years of Age; mRNA-1647-P104
This study it to test an investigational vaccine called mRNA-1647 that is being developed for preventing cytomegalovirus (CMV) infection in people. CMV is a common virus that can spread easily through an infected person’s saliva or other body fluids such as blood, urine, and breast milk. We want see if the trial vaccine can prevent CMV infection in participants who have not been previously infected, to understand the safety (how many side effects you may have) of the trial vaccine, and to see if the trial vaccine results in participants making antibodies to CMV.
• female or male 9 to 15 years of age
• in good general health
• BMI requirements ( study staff will review)
• female participants of childbearing potential: negative pregnancy test and adequate contraception for at least 28 days prior to receiving vaccine through 3 months following vaccine administration
• received, or plans to receive, any nonstudy vaccine less than 28 days prior to or after any study medication
• any diagnosis or condition requiring significant changes in management or medication within the 2 months before starting the study
• contact study staff for review of additional exclusion criteria
A Window of Opportunity Trial of Mirdametinib plus Vorinostat for NF1 Associated, Malignant Peripheral Nerve Sheath Tumor; MPNST (Le-Na)
This is a small, Phase 0, window of opportunity study to provide human experience to support our pre-clinical data and gain preliminary information regarding the safety and tolerability of mirdametinib and vorinostat when given in combination.
• Known Neurofibromatosis type 1 (NF-1) syndrome based on current diagnostic criteria
• Diagnosis of suspected MPNST by PET or MRI imaging
• Confirmation of histone H3 lysine 27 trimethylation-negative MPSNT by immunohistochemistry
• Twelve years of age or older - Complete blood count (CBC), platelet, liver and kidney function within institutional normal limits performed within 14 days of 1st dose of study drug
• Must be able to swallow capsules
• Females of childbearing potential must use highly effective contraception (see inclusion criteria section) from the time of study enrollment through 6 months after the last dose of vorinostat and mirdametinib
• Males with partners of childbearing potential must use highly effective contraception from the time of study enrollment through 3 months after the last dose of vorinostat
• Provides voluntary written consent prior to any study related activities, with parental/guardian consent and assent for those 12 to 17 years of age at enrollment
• Pregnant or breastfeeding – females of childbearing potential must have a negative pregnancy test (serum and urine) within 7 days prior to the 1st dose of the study drugs
• Significant cardiac disease
• Ophthalmologic conditions
• Radiation therapy or chemotherapy in the past year
• Participants receiving systemic or ocular glucocorticoid therapy within 14 days prior to the first dose of study treatment
Impact of a full-mouth electronic toothbrush on indicators of gingivitis and patient perceptions: A randomized clinical trial
The purpose of this trial is to investigate a full-mouth electronic toothbrush (FMET) and foam system compared to a conventional electronic toothbrush (ETB) and dentifrice during a 30-day period to evaluate the impact on clinical indicators of gingivitis, plaque, safety, and patient perceptions.
• diagnosis of mild to moderate gingivitis
• minimum of five natural teeth in each quarter of the mouth
• willing to stop all professional oral hygiene care
• willing to stop use of any other dental cleaning aids (dental floss, water flossers, interdental brushes, dental or tooth picks, mouthwash, etc.)
• access to personal email account and a device connected to the internet
• aggressive, necrotizing, uncommon periodontal disease, or any uncontrolled periodontal condition
• unable to independently brush teeth
• fixed prosthesis (i.e. implant retained denture), orthodontic appliance or under orthodontic treatment
• pregnant, planning to become pregnant, or unsure of pregnancy status
• use of cigarettes within the last year
MT2023-20: Hematopoietic cell transplant with reduced intensity conditioning and post-transplant cyclophosphamide for severe aplastic anemia and other forms of acquired bone marrow failure.
Although allogeneic hematopoietic cell transplant (HCT) is standard treatment for severe aplastic anemia, the use of the lower intensity conditioning drugs with a personalized dosing strategy, low dose total body irradiation (TBI) with dosing based on age and bone marrow abnormalities, and use of the drug cyclophosphamide early after transplant is a newer approach. We are studying whether this new approach is safer and more effective than our previous approach.
• 0 to 75 years old
• diagnosis of Idiopathic Severe Aplastic Anemia (SAA)
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
• women who are pregnant, breastfeeding or intending to become pregnant during the study
• uncontrolled infection
An Open-label, Single Arm, Multicenter, Phase III Study on the Efficacy, Safety,and Pharmacokinetics of FP-001 42 mg Controlled Release in Patients with Central (Gonadotropin-Dependent) Precocious Puberty
The study drug FP-001 (Leuprolide mesylate) is being developed for children that are suffering from central (gonadotropin-dependent) precocious puberty (CPP). Leuprolide has been approved in the United States (US) and the European Union (EU) as treatment for prostate cancer already, and other forms of Leuprolide from other companies have been approved for the treatment of CPP. In this clinical study, Leuprolide will be used in the form of a 6-month depot injection.
• females aged 2 to 8 years or males aged 2 to 9 years old
• diagnosis of Central Precocious Puberty (CPP) within 12 months
• additional inclusion criteria (study staff will review)
• major medical or psychiatric illness that could interfere with study visits
• history of seizures, epilepsy, and/or central nervous system disorders that may be associated with seizures or convulsions
• specific prior treatments (study staff will review)
MT2023-30: A Phase 1 Study of FT825/ONO-8250, an Off-the-Shelf CAR T-Cell Therapy, With or Without Monoclonal Antibodies, in HER2-Positive or Other Advanced Solid Tumors
The purpose of this study is to test the safety of FT825 at different doses and to understand the way the body processes and responds to FT825. The study will also find out what effects FT825, when given with or without a monoclonal antibody (cetuximab) and different chemotherapy regimens, have on cancer. FT825 is a type of cell product made up of “T cells.” T cells are part of your immune system and are important in helping fight infections. T cells are also important in eliminating cancer cells.
• diagnosis locally advanced or metastatic cancer
• cancer that is not amenable to curative therapy, with prior therapies defined by specific tumor types
• restricted from 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 complete inclusion criteria
• women who are pregnant or breastfeeding
• active central nervous system (CNS) involvement by cancer -active bacterial, fungal, or viral infections
• additional exclusion criteria (study staff will review)