Clinical trial · Observational
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
Protocol for Transgene Assay Service
NCT06357754CI-TRIAL-00101453recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukaemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Idecabtagene vicleucel | Biological | Idecabtagene Vicleucel | ALIAS |
| Lisocabtagene maraleucel | Biological | Lisocabtagene Maraleucel | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- Participants treated with idecabtagene vicleucel
- interventionNames
- Biological: Idecabtagene vicleucel
- label
- Participants treated with lisocabtagene maraleucel
- interventionNames
- Biological: Lisocabtagene maraleucel
Primary outcomes (2)
- measure
- Participant in situ hybridization (ISH) or droplet-based digital Polymerase chain reaction (ddPCR) transgene testing results
- timeFrame
- Baseline
- measure
- Participant insertion site analysis (ISA) testing results
- timeFrame
- Baseline
- description
- For participants with positive in situ hybridization (ISH) transgene or droplet-based digital polymerase chain reaction (ddPCR) transgene
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.