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Long-Term Follow-up for Gene-Modified T Cell Therapy

This study is a long-term follow-up for people who have previously received gene-modified (GM) T cell therapy in a study sponsored by Celgene, Juno Therapeutics, or BMS. The main goal is to track any delayed side effects (adverse events) and see how long the GM T cells remain in your body, for up to 15 years after your last infusion. Researchers will also analyze where the gene modification integrated into your cells. You can join this study if you've already completed or stopped participating in a previous study involving GM T cell therapy. This study is designed to gather important safety and effectiveness information over a long period.

Study design
This is an interventional study with a planned enrollment of 1541 participants. It is a long-term follow-up study for people who have already received gene-modified T cell therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 15 years from their last gene-modified T cell infusion.

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NCT03435796

Long-Term Follow-up Protocol for Participants Treated With Gene-Modified T Cells

Recruiting
PHASE2All AgesInterventional
Celgene
~1,541 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Gene-modified (GM) T cell therapy

At a glance

Recruiting sites
163 of 209 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of delayed Adverse Events (AEs)
Measured over Up to 15 years from last gene-modified (GM) T cell infusion
+7 more outcomes measured

Conditions

Neoplasms

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Neoplasm

Where it's being run

209 sites across 63 states
France17
Germany14
Spain12
Italy10
New York9
Japan9
Texas8
California7

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 protocol, as applicable.
Must understand and voluntarily sign an Informed Consent Form/Informed Assent Form prior to any study-related assessments/procedures being conducted.

What this trial measures

  • Incidence of delayed Adverse Events (AEs)Up to 15 years from last gene-modified (GM) T cell infusion
  • Persistence of GM T cell drug productsUp to 15 years from last GM T cell infusion
  • Analysis of vector integration sitesUp to 15 years from last GM T cell infusion
  • Incidence of replication-competent lentivirusesUp 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 malignanciesUp 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