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Recruiting

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

NCT06357754 · Bristol-Myers Squibb
In plain English

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Official title
Protocol for Transgene Assay Service
About this study
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.
Eligibility criteria
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 target: 50 participants
Age groups: child, adult, older_adult
Timeline
Starts: 2023-10-06
Estimated completion: 2038-10-06
Last updated: 2026-01-22
Interventions
Biological: Idecabtagene vicleucelBiological: Lisocabtagene maraleucel
Primary outcomes
  • 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)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Study Connect Contact Center www.BMSStudyConnect.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (8)
Local Institution - 0016Not Yet Recruiting
Portland, Oregon, United States
Ut SouthwesternRecruiting
Dallas, Texas, United States
Huntsman Cancer Institute at the University of UtahRecruiting
Salt Lake City, Utah, United States
Local Institution - 0004Withdrawn
Madison, Wisconsin, United States
Universitaetsklinikum Essen (AoR)Recruiting
Essen, Germany
Toyokawa City HospitalRecruiting
Toyokawa, Aichi-ken, Japan
Local Institution - 0003Withdrawn
Kumamoto, Kumamoto, Japan
Kantonsspital AarauRecruiting
Aarau, Switzerland
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 · TrialPath