ClinicalTrials.gg
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

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years 1 month later.
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

In context

Lymphoma, Non-Hodgkin

2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 287 are open to participants now.

This study's planned enrollment of 50 is below the median of 140 across 196 observational studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.

Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

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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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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 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 .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

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

06

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

07

Study locations

5 of 8 sites recruiting
  • Local Institution - 0016
    Portland, Oregon 97239-3098, United States
    Not yet recruiting
    • Site 0016 · Contact
  • Ut Southwestern
    Dallas, Texas 75235, United States
    Recruiting
    • Larry Anderson, Site 0008 · Contact214-648-5906
  • Huntsman Cancer Institute at the University of Utah
    Salt Lake City, Utah 84112, United States
    Recruiting
    • Lauren Lee, Site 0010 · Contact
  • Local Institution - 0004
    Madison, Wisconsin 53792, United States
    Withdrawn

    Not enrolling at this site.

  • Universitaetsklinikum Essen (AoR)
    Essen, 45147, Germany
    Recruiting
    • Bastian von Tresckow, Site 0001 · Contact+491631751277
  • Toyokawa City Hospital
    Toyokawa, Aichi-ken 442-8561, Japan
    Recruiting
    • Akimi Kawai, Site 0012 · Contact
  • Local Institution - 0003
    Kumamoto, Kumamoto 8608556, Japan
    Withdrawn

    Not enrolling at this site.

  • Kantonsspital Aarau
    Aarau, 5001, Switzerland
    Recruiting
    • Sabine Veronika Gerull, Site 0002 · Contact+41628386505
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06357754
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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