RecruitingNCT06357754

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


Sponsor

Bristol-Myers Squibb

Enrollment

50 participants

Start Date

Oct 6, 2023

Study Type

OBSERVATIONAL

Conditions

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

Inclusion Criteria2

  • 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 Criteria2

  • 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

BIOLOGICALIdecabtagene vicleucel

As per product label

BIOLOGICALLisocabtagene maraleucel

As per product label


Locations(8)

Local Institution - 0016

Portland, Oregon, United States

Ut Southwestern

Dallas, Texas, United States

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah, United States

Local Institution - 0004

Madison, Wisconsin, United States

Universitaetsklinikum Essen (AoR)

Essen, Germany

Toyokawa City Hospital

Toyokawa, Aichi-ken, Japan

Local Institution - 0003

Kumamoto, Kumamoto, Japan

Kantonsspital Aarau

Aarau, Switzerland

View Full Details on ClinicalTrials.gov

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NCT06357754


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