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BCMA targeted prime CAR-T cells

Phase 1

Multiple Myeloma | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Feb 25, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

BCMA targeted prime CAR-T cells · 1 trial · 3 indications

Phase 1 1
NCT04776330a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell DiseaseMultiple Myeloma
RECRUITING80 Analytics
PHASE1RECRUITING
a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell Disease
Multiple MyelomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse events that related to treatment
2 years

Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

The response rate of BCMA targeted prime CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA targeted prime CAR-T cells therapy
2 years

The response rate of BCMA targeted prime CAR-T treatment will be recorded and assessed according to the IMWG

Secondary Endpoints

Rate of BCMA targeted prime CAR-T cells in bone marrow and peripheral blood
2 years
Quantity of BCMA targeted prime CAR copies in bone marrow and peripheral blood
2 years
Quantity of clonal plasma cells in bone marrow
1 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BCMA targeted prime CAR-T cells treatEXPERIMENTALPatients will be be treated with BCMA targeted prime CAR-T cells

Interventions

NameTypeDescription
BCMA targeted prime CAR-T cellsBIOLOGICALBCMA targeted prime CAR-T cell therapy
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Signed written informed consent; 2. Diagnose as relapsed /refractory multiple myeloma or other plasma cell disease, and meet one of the following conditions: 1. Failed to standard chemotherapy regimens; 2. Relapse after complete remission, high-risk and / or refractory...

Countries:China
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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 BCMA targeted prime CAR-T cells

What is BCMA targeted prime CAR-T cells used for?

BCMA targeted prime CAR-T cells is an investigational cell therapy being studied for the treatment of multiple myeloma, including relapsed or refractory multiple myeloma and plasma cell disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does BCMA targeted prime CAR-T cells target?

BCMA targeted prime CAR-T cells targets B-cell maturation antigen (BCMA), a protein expressed on myeloma cells. The therapy is designed to recognize and attack BCMA-positive cells as part of its mechanism of action in treating multiple myeloma.

Who is developing BCMA targeted prime CAR-T cells?

BCMA targeted prime CAR-T cells is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DTIL. The company is conducting a Phase 1 clinical trial for this investigational therapy.

What phase is BCMA targeted prime CAR-T cells in?

BCMA targeted prime CAR-T cells is in Phase 1 clinical development. It is an investigational therapy that has not yet been approved by the FDA or other regulatory agencies. The ongoing Phase 1 trial is actively recruiting participants to evaluate the treatment.

What clinical trials is BCMA targeted prime CAR-T cells in?

BCMA targeted prime CAR-T cells is being evaluated in a Phase 1 clinical trial registered as NCT04776330. This open-label, uncontrolled study is recruiting approximately 80 participants in China with relapsed or refractory multiple myeloma and plasma cell disease.

Is BCMA targeted prime CAR-T cells the same as a monoclonal antibody?

BCMA targeted prime CAR-T cells is a cell therapy, not a monoclonal antibody. While the drug asset is categorized under the modality of monoclonal antibody in some databases, its mechanism involves engineered T cells targeting BCMA, distinguishing it from traditional antibody-based therapies.