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NCT06357754Recruiting

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

Bristol-Myers Squibb

Start Date

10/6/2023

Completion Date

10/6/2038

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 Criteria

Age Range: No minimum to No maximum

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.

Interventions

BIOLOGICAL

Idecabtagene vicleucel

BIOLOGICAL

Lisocabtagene maraleucel

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Conditions

Non-Hodgkin LymphomaChronic Lymphocytic LeukaemiaMultiple Myeloma

Locations

Local Institution - 0016

Portland, Oregon 97239-3098

United States

Ut Southwestern

Dallas, Texas 75235

United States

Huntsman Cancer Institute at the University of Utah

Salt Lake City, Utah 84112

United States

Local Institution - 0004

Madison, Wisconsin 53792

United States

Universitaetsklinikum Essen (AoR)

Essen, 45147

Germany

Toyokawa City Hospital

Toyokawa, Aichi-ken 442-8561

Japan

Local Institution - 0003

Kumamoto, Kumamoto 8608556

Japan

Kantonsspital Aarau

Aarau, 5001

Switzerland