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Gene-modified T cell therapy

Phase 2

Neoplasms | Gene therapy | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 2, 2026

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
UNCONTROLLED
Total Trials1
Total Enrollment1,541
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03435796Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T CellsPHASE2 RECRUITING 1,541 — — Jul 19, 2018Nov 30, 2036Jun 2, 2026205 United States, Australia +18
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Study Endpoints
Primary Endpoints
Incidence of delayed Adverse Events (AEs)
Up to 15 years from last gene-modified (GM) T cell infusion
Persistence of GM T cell drug products
Up to 15 years from last GM T cell infusion
Analysis of vector integration sites
Up to 15 years from last GM T cell infusion
Incidence of replication-competent lentiviruses
Up to 15 years from last GM T cell infusion
Physical growth as assessed by physical examination (pediatric participants only)
Up to 15 years from last GM T cells infusion or until Tanner Stage 5 is reached
Incidence of sexual maturation as assessed by the Tanner staging system (pediatric participants only)
Up to 15 years from last GM T cells infusion or until Tanner Stage 5
Proportion of participants who progressed on the study: participants with original diagnosis of malignancies
Up to 15 years from last GM T cells infusion
Overall Survival (participants with original diagnosis of malignancies)
Up to 15 years from last GM T cells infusion
Secondary Endpoints
Lymphocyte count (B-cell)
Up to 15 years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER
Treatment Arms
ArmTypeDescription
Participants exposed to Gene-modified (GM) T cell therapyOTHER -
Interventions
NameTypeDescription
Gene-modified (GM) T cell therapyGENETICNo investigational product will be administered
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Eligibility Criteria
SexALL
Healthy VolunteersNo
Study Sites205

Inclusion Criteria: * Received at least one gene-modified (GM) T-cell infusion in a previous Celgene sponsored, Juno Therapeutics, other affiliates of BMS, or Celgene alliance partner-sponsored trial, and have discontinued, or completed the post-treatment follow-up period in the parent treatment pr...

Countries:United StatesAustraliaAustriaBelgiumCanadaFinlandFranceGermanyIsraelItalyJapanNetherlandsNorwayPolandRomaniaSouth KoreaSpainSwedenSwitzerlandUnited Kingdom
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Competitive Landscape -Myeloproliferative Neoplasms 53 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY5PHASE3ACE-536, Luspatercept, Fedratinib, BMS-986158, Ruxolitinib
AbbVie, Inc.ABBV4PHASE3Navitoclax, Ruxolitinib, Celecoxib, ABBV-744, IMGN632
Novartis AG Sponsored ADRNVS3PHASE3Pelabresib, Ruxolitinib
Karyopharm Therapeutics, Inc.KPTI4PHASE3Selinexor, Ruxolitinib, Pacritinib, Momelotinib
Geron CorporationGERN2PHASE3Imetelstat, Ruxolitinib
Incyte CorporationINCY11PHASE2itacitinib, Ruxolitinib, Conditioning Regimen A, Conditioning Regimen B, Conditioning Regimen C
Merck & Co., Inc.MRK1PHASE3Bomedemstat
GSK plc Sponsored ADRGSK2PHASE2MMB, Momelotinib, Luspatercept
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Elritercept, Ruxolitinib
Eli Lilly and CompanyLLY1PHASE1LY3410738, Venetoclax, Azacitidine
Disc Medicine, Inc.IRON1PHASE1DISC-0974
Galecto, Inc.GLTO1PHASE2GB2064
Prelude Therapeutics, Inc.PRLD1PHASE1PRT12396
United Therapeutics CorporationUTHR1PHASE2bomedemstat
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT03435796lastUpdatePostDate: changed
LOWJun 2, 2026NCT03435796lastUpdatePostDate: changed
LOWJun 2, 2026NCT03435796lastUpdatePostDate: changed
LOWMay 26, 2026NCT03435796primaryCompletionDate: changed
LOWMay 24, 2026NCT03435796studyFirstPostDate: changed