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MT2020-23: A Phase I, Open-Label, Multicenter Study of FT538 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in Combination with Monoclonal Antibodies in Relapsed/Refractory Multiple Myeloma

Recruiting

This is a Phase I, open-label, multicenter study to evaluate the safety, pharmacokinetics, and anti-tumor activity of FT538 in subjects with relapsed or refractory (r/r) AML and r/r MM. Subjects will be enrolled in two stages: a dose-escalation stage and a dose-expansion stage.

I'm interested

All
18 Years and over
This study is NOT accepting healthy volunteers
Inclusion Criteria:

• Diagnosis of one of the following by treatment regimen: Regimen A (FT538 monotherapy in r/r AML)
• Primary refractory AML, or
• Relapsed AML, defined as not in CR after one or more re-induction attempts; if >60 years of age, prior re-induction therapy is not required Regimens B or C (FT538 + mAb in r/r MM)
• Regimen B only: MM that has relapsed or progressed after at least two lines of therapies, including a proteasome inhibitor and an immunomodulatory drug
• Regimen C only: MM that has relapsed or progressed after proteasome inhibitor therapy, and immunomodulatory therapy
• Regimen B and Regimen C: Measurable disease as defined in the protocol
• Capable of giving signed informed consent
• Age ≥18 years old
• Agreement to comply with study procedures as described in the Schedule of Activities
• Contraceptive use as described in the protocol
Exclusion Criteria:

• Females who are pregnant or breastfeeding
• ECOG Performance Status ≥ 2
• Evidence of insufficient hematologic function as defined in the protocol
• Evidence of insufficient organ function defined as defined by the protocol
• Clinically significant cardiovascular disease as defined by the protocol
• Known active central nervous system (CNS) involvement by malignancy
• Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment
• Currently receiving or likely to require systemic immunosuppressive therapy for any reason during the treatment period
• Clinically significant infections including HIV, HBV and HCV
• Live vaccine <6 weeks prior to start of lympho-conditioning
• Receipt of an allograft organ transplant
• Prior allogeneic HSCT or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host therapy
• Known allergy to albumin (human) or DMSO
• Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to subject
• Any medical condition or clinical laboratory abnormality that per investigator or Medical Monitor judgement precludes safe participation in and completion of the study, or which could affect compliance with protocol conduct or interpretation of results Exclusion Criteria Specific to Regimen A (r/r AML)
• Diagnosis of promyelocytic leukemia with t(15;17) translocation
• Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1 Exclusion Criteria Specific to Regimens B and C (r/r MM)
• Plasma cell leukemia defined as a plasma cell count >2000/mm3
• Leptomeningeal involvement of MM
• Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to the first dose of mAb
• Allergy or hypersensitivity to antibodies or antibody-related proteins

Drug: FT538, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Daratumumab, Drug: Elotuzumab

Acute Myeloid Leukemia, AML, Adult, Multiple Myeloma, Myeloma

Acute Myeloid Leukemia, AML, Multiple Myeloma, daratumumab, elotuzumab, NK cell, cellular therapy, allogeneic cell therapy, allogeneic cellular therapy, CD38, Anti-CD38, Clinics and Surgery Center (CSC)

Andersen Bartz - bartz121@umn.edu
Mark Juckett
Phase 1
STUDY00010225
NCT04614636
See this study on ClinicalTrials.gov

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