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Observational Study of Gene-Modified Cell Therapy and Second Cancers

This study is looking at tumor samples from patients who have received specific gene-modified cell therapies, like idecabtagene vicleucel or lisocabtagene maraleucel, and have since developed a second cancer. The purpose is to check the levels of the gene modification (transgene) in these tumor samples. This helps researchers understand if there's a connection between the cell therapy and the new cancer. You could be eligible if you've had one of these Bristol-Myers Squibb cell therapies and have been diagnosed with a qualifying second cancer, such as Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukaemia, or Multiple Myeloma. The study will measure transgene levels and insertion sites in your tumor samples. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect and analyze information without giving new treatments. It aims to include about 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures results at baseline, which means at the beginning of the study. It does not specify ongoing follow-up after this initial measurement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06357754

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

Recruiting
Not specifiedAll AgesObservational
Bristol-Myers Squibb
~50 participants
Updated 2026-01-22 on ClinicalTrials.gov
What's tested:Idecabtagene vicleucelLisocabtagene maraleucel

At a glance

Recruiting sites
5 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results
Measured over Baseline
+1 more outcome measured

Conditions

Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukaemia
Multiple Myeloma

Explore related trials

Chronic Lymphocytic LeukemiaMultiple MyelomaNon-Hodgkin Lymphoma

Where it's being run

8 sites across 8 states
Oregon1
Texas1
Utah1
Wisconsin1
Germany1
Aichi-ken1
Kumamoto1
Switzerland1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing resultsBaseline
  • Participant insertion site analysis (ISA) testing resultsBaseline

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