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

Protocol for Transgene Assay Service

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06357754

Enrollment

Registered

2024-04-10

Start date

2023-10-06

Completion date

2038-10-06

Last updated

2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukaemia, Multiple Myeloma

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.

Interventions

BIOLOGICALIdecabtagene vicleucel

As per product label

BIOLOGICALLisocabtagene maraleucel

As per product label

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

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

Countries

Germany, Japan, Switzerland, United States

Contacts

CONTACTBMS Study Connect Contact Center www.BMSStudyConnect.com

Clinical.Trials@bms.com855-907-3286

CONTACTFirst line of the email MUST contain NCT # and Site #.

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026