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RecruitingNCT06357754Updated Jan 22, 2026

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

An observational study in Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukaemia and Multiple Myeloma, sponsored by Bristol-Myers Squibb. Recruiting at 8 sites in 4 countries. Per ClinicalTrials.gov, last updated 2026-01-22.

Sponsored by Bristol-Myers Squibb · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

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.

02

Conditions studied

  • Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukaemia
  • Multiple Myeloma
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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

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

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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Participants treated with idecabtagene vicleucel

    Biological: Idecabtagene vicleucel

  • Participants treated with lisocabtagene maraleucel

    Biological: Lisocabtagene maraleucel

Interventions

  • BiologicalIdecabtagene vicleucel

    As per product label

  • BiologicalLisocabtagene maraleucel

    As per product label

05

What researchers measure

Primary outcomes

  1. Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results

    Time frame: Baseline

  2. Participant insertion site analysis (ISA) testing results

    For participants with positive in situ hybridization (ISH) transgene or droplet-based digital polymerase chain reaction (ddPCR) transgene

    Time frame: Baseline

06

Study locations

5 of 8 sites recruiting
  • Local Institution - 0016
    Portland, Oregon 97239-3098, United States
    • Site 0016 · Contact
    Not yet recruiting
  • Ut Southwestern
    Dallas, Texas 75235, United States
    • Larry Anderson, Site 0008 · Contact · 214-648-5906
    Recruiting
  • Huntsman Cancer Institute at the University of Utah
    Salt Lake City, Utah 84112, United States
    • Lauren Lee, Site 0010 · Contact
    Recruiting
  • Local Institution - 0004
    Madison, Wisconsin 53792, United States
    Withdrawn
  • Universitaetsklinikum Essen (AoR)
    Essen, 45147, Germany
    • Bastian von Tresckow, Site 0001 · Contact · +491631751277
    Recruiting
  • Toyokawa City Hospital
    Toyokawa, Aichi-ken 442-8561, Japan
    • Akimi Kawai, Site 0012 · Contact
    Recruiting
  • Local Institution - 0003
    Kumamoto, Kumamoto 8608556, Japan
    Withdrawn
  • Kantonsspital Aarau
    Aarau, 5001, Switzerland
    • Sabine Veronika Gerull, Site 0002 · Contact · +41628386505
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06357754
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Apr 10, 2024
Start date
Oct 6, 2023
Primary completion
Oct 6, 2038 (estimated)
Completion
Oct 6, 2038 (estimated)
Last update
Jan 22, 2026

Study contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com
Contact
Clinical.Trials@bms.com
855-907-3286
First line of the email MUST contain NCT # and Site #.
Contact
Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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