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

• Conditions: Chronic Lymphocytic Leukaemia; Multiple Myeloma; Non-Hodgkin Lymphoma
• Interventions: Biological: Lisocabtagene maraleucel; Biological: Idecabtagene vicleucel

• Registration Number: NCT06357754
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-06
• Study First Submitted: 2024-04-04
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-11
• Primary Completion: 2038-10-06
• Study Completion: 2038-10-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants treated with lisocabtagene maraleucel	Lisocabtagene maraleucel	-
Participants treated with idecabtagene vicleucel	Idecabtagene vicleucel	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Local Institution - 0010; 🇺🇸 Salt Lake City, Utah, United States

Local Institution - 0004; 🇺🇸 Madison, Wisconsin, United States

Kantonsspital Aarau; 🇨🇭 Aarau, Switzerland

Universitaetsklinikum Essen (AoR); 🇩🇪 Essen, Germany

Local Institution - 0003; 🇯🇵 Kumamoto-city, Kumamoto, Japan