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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Idecabtagene vicleucel
  • Lisocabtagene maraleucel

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators