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

January 21, 2026 updated by: Bristol-Myers Squibb

Protocol for Transgene Assay Service

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Contact Backup

  • Name: First line of the email MUST contain NCT # and Site #.

Study Locations

  • Germany
      • Essen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen (AoR)
        • Contact:
          • Bastian von Tresckow, Site 0001
          • Phone Number: +491631751277
  • Japan
    • Aichi-ken
      • Toyokawa, Aichi-ken, Japan, 442-8561
        • Recruiting
        • Toyokawa City Hospital
        • Contact:
          • Akimi Kawai, Site 0012
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 8608556
        • Withdrawn
        • Local Institution - 0003
  • Switzerland
      • Aarau, Switzerland, 5001
        • Recruiting
        • Kantonsspital Aarau
        • Contact:
          • Sabine Veronika Gerull, Site 0002
          • Phone Number: +41628386505
  • United States
    • Oregon
      • Portland, Oregon, United States, 97239-3098
        • Not yet recruiting
        • Local Institution - 0016
        • Contact:
          • Site 0016
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • UT Southwestern
        • Contact:
          • Larry Anderson, Site 0008
          • Phone Number: 214-648-5906
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute at The University of Utah
        • Contact:
          • Lauren Lee, Site 0010
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Withdrawn
        • Local Institution - 0004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Participants who receive a Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) that have been diagnosed with a qualifying secondary malignancy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants treated with idecabtagene vicleucel
Biological: Idecabtagene vicleucel
As per product label
Participants treated with lisocabtagene maraleucel
Biological: Lisocabtagene maraleucel
As per product label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results
Time Frame: Baseline
Baseline
Participant insertion site analysis (ISA) testing results
Time Frame: Baseline
For participants with positive in situ hybridization (ISH) transgene or droplet-based digital polymerase chain reaction (ddPCR) transgene
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2023

Primary Completion (Estimated)

October 6, 2038

Study Completion (Estimated)

October 6, 2038

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 9, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA082-085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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