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RecruitingObservational

Protocol for Transgene Assay Service

NCT ID: NCT06357754Sponsor: Bristol-Myers SquibbLast updated: 2026-01-22

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

Sex: AllAge: All ages
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 locations (4)

Local Institution - 0016

Portland, Oregon, 97239-3098

Not Yet Recruiting
Site 0016 · Contact

Ut Southwestern

Dallas, Texas, 75235

Recruiting
Larry Anderson, Site 0008 · Contact

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, 84112

Recruiting
Lauren Lee, Site 0010 · Contact

Local Institution - 0004

Madison, Wisconsin, 53792

Withdrawn
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 | Cancerify