FT576 in Subjects With Multiple Myeloma

• Status: Recruiting
• Trial end date: 2040-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fate Therapeutics
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Daratumumab; Fludarabine

Criteria

• 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 mg/24 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 PI

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/µL without growth factor support ≤7 days prior to measurement

• Platelet count <75,000/µL without platelet transfusion ≤72 hours prior to measurement

Evidence of insufficient organ function

• CrCL <50 ml/min 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 prior central nervous system (CNS) involvement of MM must have completed effective treatment of their CNS disease 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 systemic 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

Prior allogeneic HSCT or allogeneic CAR T/CAR NK within 6 months of Day 1, or ongoing requirement for systemic graft-versus-host therapy

Plasma cell leukemia defined as a plasma cell count >2000/mm^3

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 Day 1 or five half-lives, whichever is shorter; Investigational therapy within 30 days prior to the first dose of study treatment or five half-lives, whichever is shorter; Biologic therapy (except for anti-CD38 mAbs), including antibody-drug conjugates or bi-specific immune-cell engaging antibody within 30 days prior to Day 1

• 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