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

Last updated: April 10, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

N/A

Condition

Non-hodgkin's Lymphoma

Cancer/tumors

White Cell Disorders

Treatment

Idecabtagene vicleucel

Lisocabtagene maraleucel

Clinical Study ID

NCT06357754
CA082-085
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Participant has received a commercially available Bristol-Myers Squibb (BMS)manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with aqualifying second primary malignancy or a second primary malignancy which BMS hasqualified for testing.

  • Participant has received a commercially available BMS manufactured GMCT in aclinical trial or other investigational setting (including non-conforming product)for which there is no testing protocol in place for that trial or investigationalsetting and has been diagnosed with a qualifying second primary malignancy or asecond primary malignancy which BMS has qualified for testing.

Exclusion

Exclusion Criteria:

  • Participant is actively participating in a clinical trial where information andsample collection is being conducted under that clinical trial.

  • Participant has not received a BMS manufactured GMCT or has not been diagnosed witha qualifying second primary malignancy.

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Idecabtagene vicleucel
Phase:
Study Start date:
October 06, 2023
Estimated Completion Date:
October 06, 2038

Connect with a study center

  • CellCarta

    Antwerp,
    Belgium

    Site Not Available

  • Universitaetsklinikum Essen (AoR)

    Essen, 45147
    Germany

    Active - Recruiting

  • Kumamoto University

    Kumamoto-city, Kumamoto 8608556
    Japan

    Active - Recruiting

  • Local Institution - 0003

    Kumamoto-city, Kumamoto 8608556
    Japan

    Site Not Available

  • Kantonsspital Aarau

    Aarau, 5001
    Switzerland

    Active - Recruiting

  • Bristol-Myers Squibb

    Boudry,
    Switzerland

    Site Not Available

  • Local Institution - 0010

    Salt Lake City, Utah 84112
    United States

    Site Not Available

  • Local Institution - 0004

    Madison, Wisconsin 53792
    United States

    Site Not Available

  • University Of Wisconsin

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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