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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04776330a Clinical Research of BCMA-Targeted Prime CAR-T Cell Therapy in Relapsed/Refractory Multiple Myeloma and Plasma Cell DiseasePHASE1 RECRUITING 80Mar 7, 2021Jul 1, 2027Feb 25, 20251 China
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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 — 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 228 trials
CompanyTickerTrialsLead PhaseDrugs
Johnson & JohnsonJNJ30PHASE3Daratumumab, Lenalidomide, Bortezomib, Dexamethasone, Cilta-cel
AbbVie, Inc.ABBV16PHASE3Pomalidomide, Dexamethasone, Venetoclax, Etentamig, Carfilzomib
Bristol-Myers Squibb CompanyBMY19PHASE3Mezigdomide, Carfilzomib, Dexamethasone, Daratumumab, Bortezomib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK5PHASE3IGI, 10%, Clarithromycin, Dexamethasone, Ixazomib, Pomalidomide
GSK plc Sponsored ADRGSK17PHASE3Belantamab mafodotin, Pomalidomide, Dexamethasone, Bortezomib, Daratumumab
Regeneron Pharmaceuticals, Inc.REGN12PHASE3Linvoseltamab, Daratumumab, Carfilzomib, Dexamethasone, Pomalidomide
Pfizer Inc.PFE12PHASE3Elranatamab, Lenalidomide, Elotuzumab, Pomalidomide, Dexamethasone
Sanofi SA Sponsored ADRSNY18PHASE3Isatuximab, 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, Bortezomib
Grifols, S.A. Sponsored ADR Class BGRFS1PHASE3Xembify
BioLineRX Ltd. Sponsored ADRBLRX1PHASE3BL-8040 /kg + G-CSF
C4 Therapeutics, Inc.CCCC3PHASE2Cemsidomide, Dexamethasone, cemsidomide, Elranatamab
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
Eli Lilly and CompanyLLY1PHASE1LOXO-338, Pirtobrutinib
Moderna, Inc.MRNA2PHASE1mRNA-2808
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04776330studyFirstPostDate: changed