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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

RecruitingObservational study

Protocol for Transgene Assay Service

Who can join

All ages · All sexes

Full 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.

About the study

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.

What is being tested

Idecabtagene vicleucel (biological)
Lisocabtagene maraleucel (biological)

Sponsor: Bristol-Myers Squibb · Participants: 50 · Started: Oct 6, 2023

Contact the study team

BMS Study Connect Contact Center www.BMSStudyConnect.com · Phone: 855-907-3286

Official record on ClinicalTrials.gov — NCT06357754

Locations in the U.S.

Oregon	Local Institution - 0016, Portland (Not yet recruiting)
Texas	Ut Southwestern, Dallas
Utah	Huntsman Cancer Institute at the University of Utah, Salt Lake City

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.