Under construction – not a live service
Sign in
Taking people in United StatesNo phase

Tests tumor samples from people treated with a gene-modified cell therapy

Checks tumor samples for the therapy's genetic marker in people with a second cancer.

Key facts

Who runs it
Bristol-Myers Squibb
Where
Dallas, Madison, Portland, and Salt Lake City, United StatesSee the 4 sitesAlso in 3 other countries, 4 sites
Trial code
Registry title
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
Status
Recruiting
People taking part
50 people, planned
Started
6 Oct 2023
Expected to end
6 Oct 2038
Type of study
Observational, 2 groups
Treatments tested
  • Idecabtagene vicleucel
  • Lisocabtagene maraleucel
Record updated
22 January 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The service is looking for people who had a Bristol-Myers Squibb gene modified cell therapy and then developed a qualifying second primary cancer. Their tumor sample is tested for transgene levels.

Sex
All sexes can join.
Disease stage
A qualifying second primary malignancy, or a second primary malignancy which BMS has qualified for testing.
Earlier treatment
Must have received a commercially available Bristol-Myers Squibb (BMS) manufactured gene modified cell therapy (GMCT), also in a clinical trial or other investigational setting with no testing protocol of its own.

Main reasons for not taking part

  • Actively taking part in a clinical trial where information and samples are collected under that trial
  • Has not received a BMS manufactured gene modified cell therapy
  • Has not been diagnosed with a qualifying second primary malignancy

The registry criteria, word for word

Show all 4 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Participant has not received a BMS manufactured GMCT or has not been diagnosed with a qualifying second primary malignancy
  • Participant is actively participating in a clinical trial where information and sample collection is being conducted under that clinical trial

Where in United States

Also in 3 other countries, 4 sites

  • UT SouthwesternDallas, United StatesContact: Larry Anderson, Site 0008Taking people
  • Madison, WisconsinHospital not named in the registryNo longer taking part
  • Portland, OregonHospital not named in the registryContact: Site 0016Not yet recruiting
  • Huntsman Cancer Institute at the University of UtahSalt Lake City, United StatesContact: Lauren Lee, Site 0010Taking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Participants treated with idecabtagene vicleucel

    Treatment: Idecabtagene vicleucel

  • Participants treated with lisocabtagene maraleucel

    Treatment: Lisocabtagene maraleucel

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Protocol for Transgene Assay Service
Plain-language title
Tests tumor samples from people treated with a gene-modified cell therapyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
22 January 2026