FT576 in Subjects With Multiple Myeloma

Phase 1

Active, not recruiting

• Conditions: Multiple Myeloma; Myeloma
• Interventions: Drug: FT576 (Allogenic CAR NK cells with BCMA expression); Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Bendamustine; Drug: Daratumumab

• Registration Number: NCT05182073
• Lead Sponsor: Fate Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-15
• Study Start: 2021-11-10
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-10
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-02
• Primary Completion: 2024-09
• Study Completion: 2040-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Regimens B-B4	FT576 (Allogenic CAR NK cells with BCMA expression)	FT576 single dose in combination with daratumumab in subjects with r/r MM
Regimen A1	FT576 (Allogenic CAR NK cells with BCMA expression)	FT576 multiple dose monotherapy in subjects with r/r MM
Regimens A-A4	FT576 (Allogenic CAR NK cells with BCMA expression)	FT576 single dose monotherapy in subjects with r/r MM
Regimen B1	FT576 (Allogenic CAR NK cells with BCMA expression)	FT576 multiple dose in combination with daratumumab in subjects with r/r MM
Regimens A-A4	Fludarabine	FT576 single dose monotherapy in subjects with r/r MM
Regimens B-B4	Fludarabine	FT576 single dose in combination with daratumumab in subjects with r/r MM
Regimens A-A4	Cyclophosphamide	FT576 single dose monotherapy in subjects with r/r MM
Regimens A-A4	Bendamustine	FT576 single dose monotherapy in subjects with r/r MM
Regimens B-B4	Daratumumab	FT576 single dose in combination with daratumumab in subjects with r/r MM
Regimen A1	Cyclophosphamide	FT576 multiple dose monotherapy in subjects with r/r MM
Regimen A1	Fludarabine	FT576 multiple dose monotherapy in subjects with r/r MM
Regimen A1	Bendamustine	FT576 multiple dose monotherapy in subjects with r/r MM
Regimens B-B4	Cyclophosphamide	FT576 single dose in combination with daratumumab in subjects with r/r MM
Regimens B-B4	Bendamustine	FT576 single dose in combination with daratumumab in subjects with r/r MM
Regimen B1	Cyclophosphamide	FT576 multiple dose in combination with daratumumab in subjects with r/r MM
Regimen B1	Fludarabine	FT576 multiple dose in combination with daratumumab in subjects with r/r MM
Regimen B1	Daratumumab	FT576 multiple dose in combination with daratumumab in subjects with r/r MM
Regimen B1	Bendamustine	FT576 multiple dose in combination with daratumumab in subjects with r/r MM

Primary Outcome Measures

Name	Time	Method
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
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
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)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	Up to 15 years	Time from first dose of study treatment to disease progression or relapse, or to the day of death from any cause, as determined by the investigator according to standard IMWG response criteria
Relapse-free survival (RFS) from complete response (CR)	Up to 15 years	Duration from the start of sCR or CR until the time of relapse from sCR or CR, as determined by the investigator according to standard IMWG response criteria
Pharmacokinetics (PK) of FT576	From Baseline to PTFU visit of last cycle on the study treatment (End of cycle is Day 29 from Day 1 FT576 infusion of this cycle)	Concentration of FT576 in peripheral blood following FT576 administration
Objective response rate (ORR)	From baseline tumor assessment up to approximately 2 years after last dose of FT576	Proportion of subjects with a best overall response of sCR, CR, VGPR, or PR, as determined by the investigator according to standard IMWG response criteria
Overall survival (OS)	Up to 15 years	Time from first dose of study treatment to death from any cause
Duration of response (DOR)	Up to 15 years	Duration from the first occurrence of a documented objective response until the time of disease progression or relapse, or death due to progressive disease, as determined by the investigator according to standard IMWG response criteria

Trial Locations

Locations (14)

Texas Oncology-Medical City Dallas; 🇺🇸 Dallas, Texas, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Virginia Oncology Associates; 🇺🇸 Norfolk, Virginia, United States

Oncology Hematology Care, Inc; 🇺🇸 Cincinnati, Ohio, United States

Scri-Cbci; 🇺🇸 Denver, Colorado, United States

University of Minnesota; 🇺🇸 Saint Paul, Minnesota, United States

Medical Oncology Hematology Consultants; 🇺🇸 Newark, Delaware, United States

Tennessee Oncology - Nashville; 🇺🇸 Nashville, Tennessee, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

City of Hope; 🇺🇸 Duarte, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Roswell Park; 🇺🇸 Buffalo, New York, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Levine Cancer Institute; 🇺🇸 Charlotte, North Carolina, United States