FT576 in Subjects With Multiple Myeloma

  • STATUS
    Recruiting
  • End date
    Feb 12, 2040
  • participants needed
    168
  • sponsor
    Fate Therapeutics
Updated on 12 May 2022
fludarabine
measurable disease

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.

Details
Condition Multiple Myeloma, Myeloma
Treatment cyclophosphamide, Fludarabine, Daratumumab, FT576, FT576 (Allogenic CAR NK cells with BCMA expression)
Clinical Study IdentifierNCT05182073
SponsorFate Therapeutics
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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

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
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