FT576 in Subjects With Multiple Myeloma

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Overview

To evaluate the safety and tolerability of FT576 when administered as monotherapy and in combination with daratumumab.

SparkCures ID 1226
Trial Phase Phase 1
Enrollment 31 Patients
Treatments
Tags
  • Natural Killer (NK) Cells (Allogeneic)
Trial Sponsors
  • Fate Therapeutics
NCT Identifier

NCT05182073

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

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