FT576 in Subjects With Multiple Myeloma

NCT05182073 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: FT576-101
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Multiple Myeloma; Myeloma

Keywords

Multiple Myeloma; daratumumab; CAR NK cell; cellular therapy; relapsed/refractory multiple myeloma; allogeneic natural killer cells; anti-CD38 monoclonal antibody; chimeric antigen receptor (CAR); BCMA; anti-B-cell maturation antigen (BCMA); natural killer (NK) cell

Outcome Measures

Primary Outcomes (3)

• Incidence and nature of DLTs within each dose-escalation cohort to determine the MTD or MAD

  Cycle 1 Day -5 to Day 29 for Regimen A and A1; Cycle 1 Day -11 to Day 29 (each cycle is 40 days) for Regimen B and B1

• Determine the RP2D which will be based on the overall safety and anti-tumor activity among the dose escalation and dose expansion cohorts

  From FPI to LPI's end of Cycle 1 study treatment (End of cycle is Day 29 from Day 1 FT576 infusion)

• Incidence, nature, and severity of adverse events

  Cycle 1 Day -5 to Day 29 for Regimen A and A1; Cycle 1 Day -11 to Day 29 (each cycle is 40 days) for Regimen B and B1

Secondary Outcomes (6)

• Objective response rate (ORR)

  From baseline tumor assessment up to approximately 2 years after last dose of FT576

• Duration of response (DOR)

  Up to 15 years

• Progression-free survival (PFS)

  Up to 15 years

• Relapse-free survival (RFS) from complete response (CR)

  Up to 15 years

• Overall survival (OS)

  Up to 15 years

Study Arms (4)

Regimens A-A4

EXPERIMENTAL

FT576 single dose monotherapy in subjects with r/r MM

Drug: FT576 (Allogenic CAR NK cells with BCMA expression); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine

Regimen A1

EXPERIMENTAL

FT576 multiple dose monotherapy in subjects with r/r MM

Drug: FT576 (Allogenic CAR NK cells with BCMA expression); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine

Regimens B-B4

EXPERIMENTAL

FT576 single dose in combination with daratumumab in subjects with r/r MM

Drug: FT576 (Allogenic CAR NK cells with BCMA expression); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Daratumumab; Drug: Bendamustine

Regimen B1

EXPERIMENTAL

FT576 multiple dose in combination with daratumumab in subjects with r/r MM

Drug: FT576 (Allogenic CAR NK cells with BCMA expression); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Daratumumab; Drug: Bendamustine

Interventions

FT576 (Allogenic CAR NK cells with BCMA expression) DRUG

Experimental Interventional Therapy: FT576 comprises allogeneic natural killer (NK) cells, derived from a clonal, CD38-knockout, human-induced pluripotent stem cell line (iPSC) that expresses anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR), high-affinity, non-cleavable CD16 (hnCD16), and IL-15/IL-15 receptor fusion protein (IL-15RF).

Regimen A1; Regimen B1; Regimens A-A4; Regimens B-B4

Cyclophosphamide DRUG

Conditioning Agent

Regimen A1; Regimen B1; Regimens A-A4; Regimens B-B4

Fludarabine DRUG

Conditioning Agent

Regimen A1; Regimen B1; Regimens A-A4; Regimens B-B4

Daratumumab DRUG

Anti-CD38 Monoclonal Antibody

Also known as: Darzalex, Darzalex Faspro

Regimen B1; Regimens B-B4

Bendamustine DRUG

Conditioning Agent

Also known as: Bendeka, Treanda

Regimen A1; Regimen B1; Regimens A-A4; Regimens B-B4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 - A4 only: MM relapsed or progressed after ≥3 prior approved therapies, including an IMiD, proteosome inhibitor, and anti-CD38 mAb
• Regimens B - B4 only: 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Fate Therapeutics: lead

Study Sites (14)

University of Alabama at Birmingham

Birmingham, Alabama, 35205, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Scri-Cbci

Denver, Colorado, 80218, United States

Location

Medical Oncology Hematology Consultants

Newark, Delaware, 19713, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Minnesota

Saint Paul, Minnesota, 55108, United States

Location

Washington University

St Louis, Missouri, 63130, United States

Location

Roswell Park

Buffalo, New York, 14263, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

Location

Oncology Hematology Care, Inc

Cincinnati, Ohio, 45226, United States

Location

Tennessee Oncology - Nashville

Nashville, Tennessee, 37203, United States

Location

Texas Oncology-Medical City Dallas

Dallas, Texas, 75230, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Related Links

• ASH Dec 2020 Abstract

MeSH Terms

Conditions

Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Cyclophosphamide; fludarabine; daratumumab; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Fate Trial Disclosure

  Fate Therapeutics, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: January 10, 2022
• Study Start: November 10, 2021
• Primary Completion: September 20, 2024
• Study Completion: October 18, 2024
• Last Updated: December 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)