Testing tumor samples from patients with second cancers after gene therapy
Official title: Protocol for Transgene Assay Service
Run by Bristol-Myers Squibb · NCT06357754 · Data updated 2026-11-12
This study is testing tumor samples from patients who have had gene therapy to see if there's a link between the treatment and the development of a second cancer.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 8 sites (Portland, Oregon and 7 other locations) |
| Status | Recruiting |
| Started | October 6, 2023 |
| Main results expected | October 6, 2038 |
| Study ends | October 6, 2038 |
| Registry record updated | January 22, 2026 |
| Trial ID | NCT06357754 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients who have received a Bristol-Myers Squibb manufactured gene modified cell therapy and have a qualifying second primary malignancy.
✕Probably not a fit
Patients who have not received a BMS manufactured gene modified cell therapy or do not have a qualifying second primary malignancy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates tumor samples for transgene levels in patients who have received a gene modified cell therapy from Bristol-Myers Squibb and have been diagnosed with a qualifying second primary malignancy. The study aims to understand the relationship between the gene therapy and the occurrence of second malignancies. Participants must have received the therapy and have a qualifying diagnosis to be eligible for the transgene assay testing service.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and efficacy of gene modified cell therapies in relation to secondary malignancies.
How similar studies have gone: While this approach is focused on a specific gene therapy and its effects on secondary malignancies, similar studies have shown promise in understanding the long-term effects of gene therapies.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant has received a commercially available Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing. * Participant has received a commercially available BMS manufactured GMCT in a clinical trial or other investigational setting (including non-conforming product) for which there is no testing protocol in place for that trial or investigational setting and has been diagnosed with a qualifying second primary malignancy or a second primary malignancy which BMS has qualified for testing. Exclusion Criteria: * Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial. * Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy.
Where it's running
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Ut Southwestern
Dallas, Texas, United States Recruiting -
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States Recruiting -
Universitaetsklinikum Essen (AoR)
Essen, Germany Recruiting -
Toyokawa City Hospital
Toyokawa, Aichi-ken, Japan Recruiting -
Kantonsspital Aarau
Aarau, Switzerland Recruiting -
Local Institution - 0016
Portland, Oregon, United States Not yet recruiting
Show 2 more locations
-
Local Institution - 0004
Madison, Wisconsin, United States Withdrawn -
Local Institution - 0003
Kumamoto, Kumamoto, Japan Withdrawn
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.