NCT06357754Recruiting
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
Bristol-Myers Squibb
Start Date
10/6/2023
Completion Date
10/6/2038
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 Criteria
Age Range: No minimum to No maximum
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.
Interventions
BIOLOGICAL
Idecabtagene vicleucel
BIOLOGICAL
Lisocabtagene maraleucel
Conditions
Non-Hodgkin LymphomaChronic Lymphocytic LeukaemiaMultiple Myeloma
Locations
Local Institution - 0016
Portland, Oregon 97239-3098
United States
Ut Southwestern
Dallas, Texas 75235
United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah 84112
United States
Local Institution - 0004
Madison, Wisconsin 53792
United States
Universitaetsklinikum Essen (AoR)
Essen, 45147
Germany
Toyokawa City Hospital
Toyokawa, Aichi-ken 442-8561
Japan
Local Institution - 0003
Kumamoto, Kumamoto 8608556
Japan
Kantonsspital Aarau
Aarau, 5001
Switzerland