Protocol for Transgene Assay Service
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.
Arms & interventions
- BiologicalIdecabtagene vicleucel
As per product label
- BiologicalLisocabtagene maraleucel
As per product label
Outcome measures
Primary
Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results
Time frame: Baseline
Participant insertion site analysis (ISA) testing results
For participants with positive in situ hybridization (ISH) transgene or droplet-based digital polymerase chain reaction (ddPCR) transgene
Time frame: Baseline
Eligibility criteria
Study locations (4)
Local Institution - 0016
Portland, Oregon, 97239-3098
Ut Southwestern
Dallas, Texas, 75235
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112
Local Institution - 0004
Madison, Wisconsin, 53792