Clinical trial · Interventional
Study of BMS-986453 in Newly Diagnosed Multiple Myeloma
A Phase 1b Study of BMS-986453, Dual Targeting BCMAxGPRC5D Chimeric Antigen Receptor T Cells, in Participants With Newly Diagnosed Multiple Myeloma
NCT07333261CI-TRIAL-00103268recruitingPhase 1ClinicalTrials.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)
This is a phase 1b study evaluating if BMS-986453 is safe and effective in treating people who have newly diagnosed multiple myeloma after completing initial therapy (induction) when a stem cell transplant is not intended.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986453 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single dose BMS-986453
- description
- Participants will be treated with fludarabine IV (30 mg/m2/day) and cyclophosphamide IV (300 mg/m2/day) for 3 days prior to BMS-986453 infusion. A single dose of BMS-986453 administered by IV infusion.
- interventionNames
- Drug: BMS-986453
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
- timeFrame
- Baseline up to 5 years
- description
- Evaluate the safety and tolerability of BMS-986453 in participants with NDMM.
Secondary outcomes (10)
- measure
- Overall Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 years with no upper age limit 2. NDMM with indication for initiation of therapy diagnosed within last 12 months. Pretreatment parameters necessary for disease characterization and response assessment must be available. 3. Not eligible for ASCT by institutional criteria or deferring ASCT due to personal preference. 4. ECOG performance status 0-1 5. Adequate organ function Exclusion Criteria: 1. Known active or history of central nervous system (CNS) involvement of MM. 2. Plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS or clinically significant amiloidosis. 3. Prior history of other malignancies 4. Uncontrolled infection Other protocol-defined Inclusion/Exclusion criteria apply.
References
Publications (0)
Data not yet available
No reference posted for this study.