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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- No age limits stated
- Sex
- All sexes
- Healthy volunteers
- Not stated
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This testing service checks tumor samples for levels of a gene added during cell therapy. It is for people who received a Bristol-Myers Squibb (BMS) gene-modified cell therapy and later had a new, separate cancer that qualifies for testing.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You received a BMS gene-modified cell therapy—a treatment using cells with changed genes—that is available for sale, and you have a new, separate cancer that qualifies for testing.
- You may also qualify if you received this therapy in a clinical trial or other research setting, including a product that did not meet all product standards. That setting must have no testing plan in place, and your new, separate cancer must qualify for testing.
Who can't join
- You are currently in a clinical trial that is collecting your information and samples.
- You have not received a BMS gene-modified cell therapy, or you do not have a new, separate cancer that qualifies for testing.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (4)
OR
- Local Institution - 0016 · Portland, OR 97239-3098Site 0016 · Study contactMore trials in Portland
TX
- Ut Southwestern · Dallas, TX 75235Larry Anderson, Site 0008 · Study contact · 214-648-5906More trials in Dallas
UT
- Huntsman Cancer Institute at the University of Utah · Salt Lake City, UT 84112Lauren Lee, Site 0010 · Study contactMore trials in Salt Lake City
WI
- Local Institution - 0004 · Madison, WI 53792More trials in Madison