Recruiting

Gene Modified TherapyTransgene 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

Sponsor:

Bristol-Myers Squibb

Code:

NCT06357754

Conditions

Non-Hodgkin Lymphoma

Chronic Lymphocytic Leukaemia

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Idecabtagene vicleucel

Lisocabtagene maraleucel

Study Details

Brief 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.

Conditions

Non-Hodgkin Lymphoma

Chronic Lymphocytic Leukaemia

Multiple Myeloma

Study ID

NCT06357754

Start date

Oct 6, 2023

Status verified date

Jan, 2026

Completion date

Oct 6, 2038

Anticipated

Primary completion date

Oct 6, 2038

Anticipated

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants treated with idecabtagene vicleucel

Participants treated with lisocabtagene maraleucel

Interventions

Idecabtagene vicleucel

As per product label

Lisocabtagene maraleucel

As per product label

Primary outcome measure

Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results [ Time Frame: Baseline ]
Participant insertion site analysis (ISA) testing results [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

855-907-3286 Clinical.Trials@bms.com

Locations

Ut Southwestern

Recruiting

Dallas, Texas, United States, 75235

Contacts

Larry Anderson, Site 0008

214-648-5906

Huntsman Cancer Institute at the University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Jan 22, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-01-22.