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
Sponsor study identifier
observational
50
4 countries
8
Study Start
October 6, 2023
Actual (reported)Primary Completion
October 6, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
October 6, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 6, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 6, 2023
Actual (reported)April 4, 2024
Actual (reported)April 10, 2024
Actual (reported)October 6, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
October 6, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results
Baseline
Participant insertion site analysis (ISA) testing results
For participants with positive in situ hybridization (ISH) transgene or droplet-based digital polymerase chain reaction (ddPCR) transgene
Baseline
As per product label
As per product label
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Participants who receive a Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) that have been diagnosed with a qualifying secondary malignancy
Local Institution - 0016
Portland, Oregon, 97239-3098, United States
Ut Southwestern
Dallas, Texas, 75235, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112, United States
Acceptable sample types for transgene testing include: * Formalin fixed paraffin embedded (FFPE) tumor sample (twenty 4-5 μm freshly cut sections) * Bone marrow aspirate (up to 6mL. minimum of 4mL) * FFPE bone marrow biopsy (twenty 4-5 μm freshly cut sections) * Peripheral blood (6ml)
Bristol-Myers Squibb
Bristol-Myers Squibb
First line of the email MUST contain NCT # and Site #.
CONTACT
First Submitted
April 4, 2024
First Posted
April 10, 2024
Study Start
October 6, 2023
Actual (reported)Primary Completion
October 6, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Local Institution - 0004
Madison, Wisconsin, 53792, United States
Universitaetsklinikum Essen (AoR)
Essen, 45147, Germany
Toyokawa City Hospital
Toyokawa, Aichi-ken, 442-8561, Japan
Local Institution - 0003
Kumamoto, Kumamoto, 8608556, Japan
Kantonsspital Aarau
Aarau, 5001, Switzerland
Study Completion
October 6, 2038
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 22, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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