RECRUITINGOBSERVATIONAL
Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Second Primary Malignancy
Protocol for Transgene Assay Service
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
BIOLOGICAL
Idecabtagene vicleucel
As per product label
BIOLOGICAL
Lisocabtagene maraleucel
As per product label
Locations (8)
Local Institution - 0016
Portland, Oregon, United States
Ut Southwestern
Dallas, Texas, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States
Local Institution - 0004
Madison, Wisconsin, United States
Universitaetsklinikum Essen (AoR)
Essen, Germany
Toyokawa City Hospital
Toyokawa, Aichi-ken, Japan
Local Institution - 0003
Kumamoto, Kumamoto, Japan
Kantonsspital Aarau
Aarau, Switzerland