Protocol for Transgene Assay Service
Bristol-Myers Squibb
Summary
The purpose of this transgene assay testing service is to evaluate tumor samples for transgene levels in patients who received a commercially available Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying second malignancy.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- Not specified
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…
Interventions
- BiologicalIdecabtagene vicleucel
As per product label
- BiologicalLisocabtagene maraleucel
As per product label
Locations (8)
- Local Institution - 0016Portland, Oregon
- Ut SouthwesternDallas, Texas
- Huntsman Cancer Institute at the University of UtahSalt Lake City, Utah
- Local Institution - 0004Madison, Wisconsin
- Universitaetsklinikum Essen (AoR)Essen
- Toyokawa City HospitalToyokawa, Aichi-ken