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Gene-modified T cell therapy

Phase 2

Neoplasms | Gene therapy | Oncology |Bristol-Myers Squibb Company|Last Updated: Sep 4, 2026

Target and mechanism

ModalityGene therapy

Also known as Gene-modified (GM) T cell therapy

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment1,541

FDA Designations

No designations recorded

Clinical trial landscape

Gene-modified T cell therapy · 1 trial · 1 indication

Phase 2 1
NCT03435796Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T CellsNeoplasms
RECRUITING1,541 Analytics
PHASE2RECRUITING
Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells
NeoplasmsUnlock trial analytics

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 Sites213

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 StatesAustraliaAustriaBelgiumCanadaFinlandFranceGermanyGreeceIsraelItalyJapanNetherlandsNorwayPolandRomaniaSouth KoreaSpainSwedenSwitzerlandUnited Kingdom
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Recent Changes (Last 90 Days)

LOWSep 4, 2026NCT03435796lastUpdatePostDate: changed
LOWJul 30, 2026NCT03435796lastUpdatePostDate: changed
LOWJul 30, 2026NCT03435796lastUpdatePostDate: changed
LOWJul 10, 2026NCT03435796lastUpdatePostDate: changed
LOWJul 10, 2026NCT03435796lastUpdatePostDate: changed

Frequently asked questions about Gene-modified T cell therapy

What is Gene-modified T cell therapy used for?

Gene-modified T cell therapy is an investigational gene therapy being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who is developing Gene-modified T cell therapy?

Gene-modified T cell therapy is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational therapy.

What phase is Gene-modified T cell therapy in?

Gene-modified T cell therapy is currently in Phase 2 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory agencies such as the FDA. The therapy is being studied in an ongoing clinical trial to assess its long-term effects in patients.

What clinical trials is Gene-modified T cell therapy in?

Gene-modified T cell therapy is being evaluated in a single clinical trial registered as NCT03435796. This Phase 2 study, titled 'Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells,' is currently recruiting participants with neoplasms across multiple countries, including the United States, Australia, and several European and Asian nations.

Is Gene-modified T cell therapy the same as Gene-modified (GM) T cell therapy?

Yes, Gene-modified T cell therapy is also known as Gene-modified (GM) T cell therapy. These names refer to the same investigational therapy being developed by Bristol-Myers Squibb. The therapy involves modifying a patient's T cells to target and potentially treat neoplasms.