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NCT06357754 Clinical Trial

Transgene Assay Testing Service of Tumor Samples From Patients Who Received a Bristol-Myers Squibb Manufactured Gene Modified Cell Therapy and Have a Qualifying Secondary Malignancy

Multiple Myeloma Clinical Trial

Official title:
Protocol for Transgene Service Assay

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06357754
Other study ID # CA082-085
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 6, 2023
Est. completion date October 6, 2038

Study information
Verified date April 2024
Source Bristol-Myers Squibb
Contact BMS Study Connect Contact Center www.BMSStudyConnect.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this transgene assay testing service is to evaluate the tumor samples for transgene levels in patients who received a Bristol-Myers Squibb manufactured gene modified cellular therapy and have reported a qualifying secondary malignancy.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date October 6, 2038
Est. primary completion date October 6, 2038
Accepts healthy volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: • Participant has received a Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a qualifying secondary malignancy suspected of T-cell origin. OR • Participant has received a Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) and has been diagnosed with a secondary malignancy qualifying for further investigation. AND • Participant is not actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial. 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 Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) or has not been diagnosed with a qualifying secondary malignancy.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Idecabtagene vicleucel
As per product label
• Lisocabtagene maraleucel
As per product label

Locations
Country Name City State
Belgium CellCarta Antwerp

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Participant in situ hybridization (ISH) transgene testing results Baseline
Primary Participant insertion site (ISA) analysis testing results For participants with positive in situ hybridization (ISH) transgene result Baseline
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