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

Bristol-Myers Squibb (BMS)

Status

Enrolling

Conditions

Multiple Myeloma

Non-Hodgkin Lymphoma

Chronic Lymphocytic Leukaemia

Treatments

Biological: Idecabtagene vicleucel

Biological: Lisocabtagene maraleucel

Study type

Observational

Funder types

Industry

Identifiers

NCT06357754

CA082-085

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.