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Daratumumab

Phase 1

Multiple Myeloma | Small molecule | Oncology |Fate Therapeutics, Inc.|Last Updated: Dec 12, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

Daratumumab · 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 221 trials

Top 20 of 25 competitors

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax
Bristol-Myers Squibb CompanyBMY18PHASE3Iberdomide, Lenalidomide
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib
Johnson & JohnsonJNJ28PHASE3Talquetamab, Pomalidomide, Teclistamab, Elotuzumab, Dexamethasone
Regeneron Pharmaceuticals, Inc.REGN11PHASE3Linvoseltamab, Carfilzomib, Daratumumab, Dexamethasone, Pomalidomide
Pfizer Inc.PFE11PHASE3Elranatamab, Lenalidomide
Sanofi SA Sponsored ADRSNY17PHASE3Isatuximab, Dexamethasone, Pomalidomide, Montelukast, Paracetamol/ Acetaminophen
AstraZeneca PLCAZN5PHASE3AZD0120, Daratumumab, Carfilzomib, Dexamethasone, Bortezomib
Gilead Sciences, Inc.GILD3PHASE3Anitocabtagene Autoleucel, Cyclophosphamide, Fludarabine, Pomalidomide, Bortezomib
Karyopharm Therapeutics, Inc.KPTI6PHASE3Selinexor, Elotuzumab, Pomalidomide, Dexamethasone
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040/kg, G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone
Cellectar Biosciences, Inc.CLRB1PHASE2Iopofosine I 131 single dose, Iopofosine I 131 fractionated dose
GeoVax Labs, Inc.GOVX1PHASE2COVID-19 Vaccine, Synthetic MVA-based SARS-CoV-2 Vaccine GEO-CM04S1
Autolus Therapeutics Plc Sponsored ADRAUTL1PHASE2AUTO CAR T cell therapy
Incyte CorporationINCY2PHASE1Ruxolitinib, Lenalidomide, Methylprednisolone
Moderna, Inc.MRNA2PHASE1mRNA-2808
BeOne Medicines Ltd. Sponsored ADRONC1PHASE1Sonrotoclax, Dexamethasone, Carfilzomib, Daratumumab, Pomalidomide
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Frequently asked questions about Daratumumab

What is Daratumumab?

Daratumumab is an investigational small molecule being developed by Fate Therapeutics, Inc. (NASDAQ: FATE) for the treatment of Multiple Myeloma. It is currently in Phase 1 clinical development and is not yet approved by the FDA.

What is Daratumumab used for in Multiple Myeloma?

Daratumumab is being studied for the treatment of Multiple Myeloma, a cancer of plasma cells. It is intended for use in adult patients aged 18 years and older. The drug is currently in Phase 1 clinical trials to evaluate its safety and efficacy in this patient population.

Who makes Daratumumab?

Daratumumab is being developed by Fate Therapeutics, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol FATE. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Multiple Myeloma.

What phase is Daratumumab in?

Daratumumab is in Phase 1 clinical development. It is an investigational drug and has not yet received FDA approval. The drug is being studied in a completed Phase 1 trial for Multiple Myeloma, with results expected to inform further development.

What clinical trials is Daratumumab in?

Daratumumab has been studied in one clinical trial, identified as NCT05182073, titled 'FT576 in Subjects With Multiple Myeloma'. This Phase 1 trial was conducted in the United States and enrolled 31 participants with Multiple Myeloma. The trial has been completed.

Is Daratumumab the same as FT576?

Yes, Daratumumab is also known as FT576. The clinical trial NCT05182073, which evaluated the drug in patients with Multiple Myeloma, used the name FT576 in its title. Both names refer to the same investigational drug being developed by Fate Therapeutics.