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FT576

Phase 1

Multiple Myeloma | Cell therapy | Oncology |Fate Therapeutics, Inc.|Trials Updated: Dec 12, 2025

FT576 target and mechanism

Molecular targetBCMA
Target classProtein
ModalityCell therapy

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

FT576 clinical trials

FT576 · 1 trial · 2 indications

Phase 1 1
NCT05182073FT576 in Subjects With Multiple MyelomaMultiple Myeloma
COMPLETED31 Analytics
PHASE1COMPLETED
FT576 in Subjects With Multiple Myeloma
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Regimens A-A4EXPERIMENTALFT576 single dose monotherapy in subjects with r/r MM
Regimen A1EXPERIMENTALFT576 multiple dose monotherapy in subjects with r/r MM
Regimens B-B4EXPERIMENTALFT576 single dose in combination with daratumumab in subjects with r/r MM
Regimen B1EXPERIMENTALFT576 multiple dose in combination with daratumumab in subjects with r/r MM

Interventions

NameTypeDescription
FT576 (Allogenic CAR NK cells with BCMA expression)DRUGExperimental 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).
CyclophosphamideDRUGConditioning Agent
FludarabineDRUGConditioning Agent
DaratumumabDRUGAnti-CD38 Monoclonal Antibody
BendamustineDRUGConditioning Agent
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

* 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 an...

Countries:United States
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Competitive Landscape -Multiple Myeloma 340 trials

Frequently asked questions about FT576

What is FT576 used for?

FT576 is an investigational cell therapy being studied for the treatment of multiple myeloma. It is designed for patients with this blood cancer and was evaluated in a Phase 1 clinical trial. It is not approved for commercial use and remains in clinical development.

What does FT576 target?

FT576 targets BCMA, a protein expressed on multiple myeloma cells. BCMA is a validated target in myeloma therapy. FT576 is an allogeneic CAR NK cell therapy engineered with BCMA expression, meaning it uses donor-derived natural killer cells modified to recognize BCMA.

Who is developing FT576?

FT576 is being developed by Fate Therapeutics, Inc., a biopharmaceutical company focused on cell therapies. The company trades on the Nasdaq under the ticker FATE. Fate Therapeutics is responsible for the clinical development of FT576.

What phase is FT576 in?

FT576 is in Phase 1 clinical development. It has completed one Phase 1 trial in multiple myeloma. It is investigational and has not been approved by the FDA for any indication.

What clinical trials is FT576 in?

FT576 has been studied in one completed Phase 1 clinical trial, NCT05182073, titled FT576 in Subjects With Multiple Myeloma. The trial enrolled 31 participants in the United States and included adult patients with multiple myeloma. No active trials are currently listed.