FT576 in Subjects With Multiple Myeloma FT576
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What's the purpose of this trial?

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

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 1

Enrollment: 204 patients (estimated)

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Published Results

Interim Phase I Clinical Data of FT576 As Monotherapy and in Combination with Daratumumab in Subjects with Relapsed/Refractory Multiple Myeloma

November 15, 2022

Results: As of a data cutoff date of 18 Jul 2022, 9 patients with R/R MM were treated and evaluable for safety and efficacy, in the first 2 dose levels of Regimen A (n = 6) and in the first dose level of Regimen B (n = 3). No dose-limiting toxicities, and no events of any grade of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome, or graft-versus-host disease (GvHD), were observed.


Conclusions: Administration of a single dose of FT576 at 100 or 300 million cells/dose alone or in combination with daratumumab is safe and well tolerated thus far without CRS, neurotoxicity, or GvHD. Interim clinical data, including safety and tolerability and initial anti-tumor activity, from the ongoing Phase I dose-escalation study of FT576 will be presented at the conference.

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Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Alabama

University of Alabama at Birmingham O'Neal Comprehensive Cancer Center

Birmingham, AL

Open and Accepting

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco

San Francisco, CA

Not Yet Accepting

City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting

Colorado

Colorado Blood Cancer Institute Sarah Cannon at Presbyterian/St. Luke's Medical Center (HealthONE)

Denver, CO

Open and Accepting

Delaware

Medical Oncology Hematology Consultants PA in ChristianaCare Helen F. Graham Cancer Center & Research Institute

Newark, DE

Open and Accepting

Indiana

Simon Cancer Center Indiana University

Indianapolis, IN

Open and Accepting

Minnesota

University of Minnesota - Masonic Cancer Center

Minneapolis, MN

Open and Accepting

Missouri

Alvin J. Siteman Cancer Center Washington University Medical Campus

St. Louis, MO

Open and Accepting

New York

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting

North Carolina

Atrium Health's Levine Cancer Institute - Charlotte (Main) Atrium Health

Charlotte, NC

Open and Accepting

Ohio

Oncology Hematology Care, Inc. - Blue Ash

Cincinnati, OH

Open and Accepting

Tennessee

Sarah Cannon Research Institute at Tennessee Oncology TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Texas

Texas Oncology - Medical City

Dallas, TX

Open and Accepting

Virginia

Virginia Oncology Associates - Lake Wright Norfolk (Lake Wright)

Norfolk, VA

Open and Accepting

Wisconsin

Medical College of Wisconsin Froedtert Hospital

Milwaukee, WI

Open and Accepting
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