A Phase 2/3 interventional study of Gene-modified (GM) T cell therapy in Neoplasms, sponsored by Celgene. Recruiting at 222 sites in 22 countries. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by Celgene · Phase 2/3, Interventional, and Other
This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.
Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
Exclusion Criteria:
Not Applicable
Other protocol-defined inclusion/exclusion criteria apply
Genetic: Gene-modified (GM) T cell therapy
No investigational product will be administered
Incidence of delayed Adverse Events (AEs)
Time frame: Up to 15 years from last gene-modified (GM) T cell infusion
Persistence of GM T cell drug products
Time frame: Up to 15 years from last GM T cell infusion
Analysis of vector integration sites
Time frame: Up to 15 years from last GM T cell infusion
Incidence of replication-competent lentiviruses
Time frame: Up to 15 years from last GM T cell infusion
Physical growth as assessed by physical examination (pediatric participants only)
Time frame: 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)
Time frame: 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
Time frame: Up to 15 years from last GM T cells infusion
Overall Survival (participants with original diagnosis of malignancies)
Time frame: Up to 15 years from last GM T cells infusion
Lymphocyte count (B-cell)
If B-cell recovery criteria are not met at Month 60 (Year 5), then annual monitoring will continue up to 15 years, until subject withdrawal of consent, or death, whichever occurs first.
Time frame: Up to 15 years
Showing the first 100 of 222 sites across 22 countries.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
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