Testing tumor samples from patients with second cancers after gene therapy
Protocol for Transgene Assay Service
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 8 sites (Portland, Oregon and 7 other locations) |
| Trial ID | NCT06357754 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Portland, Oregon and 7 other locations
- Local Institution - 0016 — Portland, Oregon, United States (Not_yet_recruiting)
- Ut Southwestern — Dallas, Texas, United States (Recruiting)
- Huntsman Cancer Institute at the University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Local Institution - 0004 — Madison, Wisconsin, United States (Withdrawn)
- Universitaetsklinikum Essen (AoR) — Essen, Germany (Recruiting)
- Toyokawa City Hospital — Toyokawa, Aichi-ken, Japan (Recruiting)
- Local Institution - 0003 — Kumamoto, Kumamoto, Japan (Withdrawn)
- Kantonsspital Aarau — Aarau, Switzerland (Recruiting)
Study contacts
- Study coordinator: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.