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ALLO-715

Phase 1

Relapsed/Refractory Multiple Myeloma | Gene therapy | Oncology |Allogene Therapeutics, Inc.|Last Updated: May 13, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment73

FDA Designations

ORPHAN_DRUGRMAT

Clinical trial landscape

ALLO-715 · 1 trial · 1 indication

Phase 1 1
NCT04093596Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)Relapsed/Refractory Multiple Myeloma
COMPLETED73 Analytics
PHASE1COMPLETED
Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Relapsed/Refractory Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-715
28 Days

Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.

To assess the overall safety profile and tolerability of ALLO-647 in combination with Fludarabine and/or cyclophosphamide or ALLO-647 alone, prior to ALLO-715 to confirm the dose of ALLO-647.
33 days

The proportion of subjects in a dose cohort with DLTs of ALLO-647

To assess the overall safety profile and tolerability of nirogacestat given concomitantly with ALLO-715 following lymphodepletion with Flu/ Cy/ ALLO-647.
28 days

Dose limiting toxicities are defined as ALLO-715-related adverse events with onset within 28 days following infusion of ALLO-715.

Secondary Endpoints

Cellular kinetics of ALLO-715
up to 60 months
antitumor activity of ALLO-715 in combination with nirogacestat
up to 60 months
Cellular kinetics of ALLO-715 in combination with nirogacestat
up to 60 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALLO-647, ALLO-715, NirogacestatEXPERIMENTAL -

Interventions

NameTypeDescription
ALLO-715GENETICALLO-715 is an allogeneic CAR T cell therapy targeting BCMA
ALLO-647BIOLOGICALALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
FludarabineDRUGChemotherapy for lymphodepletion
CyclophosphamideDRUGChemotherapy for lymphodepletion
NirogacestatDRUGa small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: * Documented diagnosis of relapsed/refractory multiple myeloma (MM) with measurable disease (serum, urine, or free light chain \[FLC\]) per International Myeloma Working Group (IMWG) criteria * At least 3 prior lines of MM therapy, including a proteasome inhibitor, immunomodulat...

Countries:United States
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Competitive Landscape -Multiple Myeloma 221 trials (matched to "Relapsed/Refractory Multiple Myeloma")

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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Recent Changes (Last 90 Days)

MEDIUMJun 13, 2026NCT04093596TRIAL_REMOVED: changed
MEDIUMJun 13, 2026NCT04093596TRIAL_REMOVED: changed
MEDIUMJun 13, 2026NCT04093596TRIAL_REMOVED: changed
MEDIUMJun 13, 2026NCT04093596TRIAL_REMOVED: changed

Frequently asked questions about ALLO-715

What is ALLO-715 used for?

ALLO-715 is an investigational allogeneic CAR T cell therapy being studied for the treatment of relapsed or refractory multiple myeloma. It is a gene therapy developed by Allogene Therapeutics, Inc. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.

What does ALLO-715 target?

ALLO-715 targets BCMA, or B-cell maturation antigen, which is expressed on multiple myeloma cells. As an allogeneic CAR T cell therapy, it is designed to recognize and attack BCMA-positive cancer cells. This mechanism is being evaluated in the Phase 1 UNIVERSAL clinical trial.

Who makes ALLO-715?

ALLO-715 is being developed by Allogene Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALLO. The company is conducting clinical research on this investigational therapy for relapsed or refractory multiple myeloma.

What phase is ALLO-715 in?

ALLO-715 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trial, known as UNIVERSAL, has been completed, and the drug has received Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations from the FDA.

What clinical trials is ALLO-715 in?

ALLO-715 is being studied in the UNIVERSAL trial, registered as NCT04093596. This Phase 1 study evaluated the safety and efficacy of ALLO-715 in adults with relapsed or refractory multiple myeloma. The trial enrolled 73 participants in the United States and has been completed.

Is ALLO-715 the same as a BCMA CAR T therapy?

ALLO-715 is an allogeneic CAR T cell therapy that targets BCMA, making it a BCMA-directed CAR T therapy. It is being developed for relapsed or refractory multiple myeloma. The drug is distinct from other BCMA CAR T therapies due to its allogeneic, or off-the-shelf, approach.