Clinical trial · Interventional
A Study to Evaluate the Safety and Tolerability of BMS-986403 in Participants With Relapsed and/or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 1, Multicenter, Open-label Study of BMS-986403 in Subjects With Relapsed and/or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
NCT05244070CI-TRIAL-00068073terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business objectives have changed.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and preliminary efficacy of BMS-986403 in participants with relapsed and/or refractory chronic lymphocytic leukemia (R/R CLL) or small lymphocytic lymphoma (SLL).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-986403 | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BMS-986403 + Fludarabine + Cyclophosphamide
- interventionNames
- Drug: BMS-986403
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (6)
- measure
- Number of participants with adverse events (AEs)
- timeFrame
- Up to 2 years after BMS-986403 infusion
- measure
- Number of participants with serious adverse events (SAEs)
- timeFrame
- Up to 2 years after BMS-986403 infusion
- measure
- Number of participants with clinical laboratory abnormalities
- timeFrame
- Up to 2 years after BMS-986403 infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and high-risk features must have failed at least 2 lines of prior therapy and participants with CLL or SLL and standard risk features must have failed at least 3 lines of prior therapy * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1 * Either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure * Has recovery to Grade ≤ 1 or baseline of any non-hematologic toxicities due to previous therapy, except alopecia (any Grade acceptable) and peripheral neuropathy (Grade ≤ 2 acceptable) Exclusion Criteria: * Any condition, including active or uncontrolled infection, or the presence of laboratory abnormalities, that places the subject at unacceptable risk if they were to participate in the study * Systemic fungal, bacterial, viral, or other infection that is not controlled * Active autoimmune disease requiring immunosuppressive therapy * Progressive deep vein thrombosis or pulmonary embolism requiring treatment, but not yet on a stable anticoagulation regimen Other protocol-defined inclusion/exclusion criteria apply
References
Publications (0)
Data not yet available
No reference posted for this study.