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

Plain Language Summary

Simplified for easier understanding

This is not a treatment trial — it is a testing service for people who previously received a specific type of gene therapy made by Bristol-Myers Squibb (BMS) and have now been diagnosed with a new, separate cancer. The program tests tumor samples to investigate whether the gene therapy may be linked to the new cancer. **You may be eligible if...** - You previously received a BMS-manufactured gene-modified cell therapy (such as a CAR-T therapy) - You have since been diagnosed with a new primary cancer (a second, unrelated cancer) - BMS has determined your new cancer qualifies for investigation - You are not already enrolled in another clinical trial that covers this type of testing **You may NOT be eligible if...** - You are currently in another clinical trial that already includes this tumor testing - Your new cancer has not been identified by BMS as qualifying for this program Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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