Multiple Myeloma Clinical Trial
FT576 in Subjects With Multiple Myeloma
This is a Phase I dose-finding study of FT576 as monotherapy and in combination with the monoclonal antibody daratumumab in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage.
Abbreviated inclusion criteria:
Diagnosis of r/r MM with measurable disease by at least one of the following:
Serum M-protein ≥1.0 g/dL
Urine M-protein ≥200 mg/24 hours
Involved serum free light chain level ≥10 mg/dL, with an abnormal kappa-lambda ratio if the serum M-protein <1.0 g/dL and/or urine M-protein <200 mg24 hours
Regimens A and A1: MM relapsed or progressed after ≥3 prior approved therapies, including an IMiD, proteosome inhibitor, and anti-CD38 mAb
Regimens B and B1: MM relapsed or progressed after ≥2 prior approved therapies, including an IMiD and proteosome inhibitor
Note: for all Regimens, prior BCMA CAR T-cell therapy and BCMA-targeted therapy (e.g., bi-specific engagers or antibody-drug conjugates) is allowed
* Abbreviated exclusion criteria:
Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≥2
Evidence of insufficient hematologic function:
ANC <1000> Platelet count <75,000/µL without platelet transfusion ≤72 hours prior to measurement
Evidence of insufficient organ function
CrCL <50 mlmin by Cockcroft-Gault or other institutional method
T bilirubin >1.5x ULN, except for Gilbert's syndrome
AST >3x ULN or ALT >3x ULN, unless directly due to underlying malignancy
O2 sat <92% on room air
Clinically significant cardiovascular disease:
Myocardial infarction within 6 months of first treatment
Unstable angina or CHF of NYHA Grade 2 or higher
Cardiac EF <40%
Subjects with active central nervous system (CNS) , including leptomeningeal disease. Subjects with prior CNS involvement may be enrolled into the study if effective treatment of their CNS disease was completed at least 3 months prior to Day 1 with no evidence of disease clinically and at least stable findings on relevant CNS imaging.
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 immunosuppressive therapy (e.g., prednisone >5 mg daily) for any reason during the treatment period, with the exception of corticosteroids.
Clinically significant infections, including:
HIV positive by serology
HBV positive by serology or PCR
HCV positive by serology or PCR
Live vaccine <6 weeks prior to start of conditioning
Receipt of an allograft organ transplant
Ongoing requirement for systemic graft -versus-host disease therapy
Plasma cell leukemia defined as a plasma cell count >2000/mm^3
Prior malignancy (other than current indication including any antecedent hematologic disorder) within the 2 years prior to enrollment except for the following: basal or squamous cell carcinomas of the skin, carcinoma in situ of the cervix or breast treated with curative intent, or localized prostate cancer treated with curative intent, or malignancy that, in the opinion of the investigator and Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years.
Washout periods from prior therapies:
For all subjects (Regimens A, A1, B and B1), receipt of the following: Chemotherapy, or radiation therapy, except for palliative purposes, within 14 days prior to the first dose of FT576 (Day 1) or five half-lives, whichever is shorter; Investigational therapy within 30 days prior to the first dose of FT576 study treatment or five half-lives, whichever is shorter; Biologic therapy (except for anti-CD38 mAbs in Regimen B and B1), including autologous cellular immunotherapy (e.g. CAR-T/ CAR-NK), antibody-drug conjugates or bi-specific immune-cell engaging antibody within 30 days prior to first dose of FT576 (Day 1) or half -lives whichever is shorter. prior allogenic HSCT or allogenic CAR-T/CAR-NK within 6 months of first dose of FT576 (Day1).
For subjects in Regimens B and B1 only, receipt of the following: Anti-CD38 therapy alone or in combination within 3 months prior to the start of daratumumab
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There are 10 Locations for this study
Birmingham Alabama, 35249, United States
Duarte California, 91010, United States
Denver Colorado, 80218, United States
Newark Delaware, 19713, United States
Indianapolis Indiana, 46202, United States
Cincinnati Ohio, 45242, United States
Nashville Tennessee, 37203, United States
Dallas Texas, 75230, United States
Norfolk Virginia, 23502, United States
Milwaukee Wisconsin, 53226, United States
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