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

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• Child, Adult, Older adult

Study population: Participants who receive a Bristol-Myers Squibb (BMS) manufactured Gene Modified Cell Therapy (GMCT) that have been diagnosed with a qualifying secondary malignancy

Trial locations and contacts

8 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Protocol for Transgene Assay Service

Conditions

Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukaemia, Multiple Myeloma

Being tested

Idecabtagene vicleucel, Lisocabtagene maraleucel

Medical subject headings

Lymphoma, Non-Hodgkin, Leukemia, B-Cell, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Idecabtagene vicleucelBiological

  As per product label

• Lisocabtagene maraleucelBiological

  As per product label

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results

   Measured: Baseline

2. 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

   Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted10 Apr 2024
2. Study start6 Oct 2023
3. Primary completion6 Oct 2038 (estimated)
4. Study completion6 Oct 2038 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
• More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.