Clinical trial · Interventional
A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma
A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma
NCT04674813CI-TRIAL-00102833completedPhase 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)
The purpose of this study is to evaluate the safety and preliminary efficacy of CC-95266 in participants with relapsed and/or refractory multiple myeloma (R/R MM).
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| CC-95266 | Drug | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Administration of CC-95266
- interventionNames
- Drug: CC-95266
- Drug: Fludarabine
- Drug: Cyclophosphamide
- Drug: Bendamustine
Primary outcomes (5)
- measure
- Number of participants with Adverse Events (AEs)
- timeFrame
- Up to 2 years after CC-95266 infusion
- measure
- Number of participants with significant laboratory abnormalities
- timeFrame
- Up to 2 years after CC-95266 infusion
- measure
- Number of participants with Dose Limiting Toxicities (DLTs)
- timeFrame
- Up to 2 years after CC-95266 infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Participant has a diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Participants must have confirmed progressive disease (as per IMWG criteria) on or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry or have confirmed progressive disease within 6 months prior to screening and who are subsequently determined to be refractory or non-responsive to their most recent anti-myeloma treatment regimen, except for participants with cellular therapy (e.g., Chimeric antigen receptor (CAR) T-cell therapy) as their last treatment, who may enroll beyond 12 months. * Participants in Part A, and Part B Cohort A, and Part B Cohort B must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without hematopoietic stem cell transplant (HSCT) and with or without maintenance therapy is considered one regimen).Subjects in Part B Cohort C only must have received at least 1 but not greater than 3 prior anti-myeloma treatment regimens, including a proteasome inhibitor and immunomodulatory agent including: * Autologous HSCT, unless the subject was ineligible * A regimen that included an immunomodulatory agent (e.g., thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (e.g., bortezomib, carfilzomib, ixazomib), either alone or combination * Anti-CD38 (e.g., daratumumab), either alone or combination. Subjects in Cohort C do not require prior anti-CD38 antibody therapy. * Measurable disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function Exclusion Criteria: * Known active or history of central nervous system (CNS) involvement of MM * Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis * Active autoimmune disease requiring immunosuppressive therapy * History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis Other protocol-defined inclusion/exclusion criteria apply.
References
Publications (1)
pubmedProvenance
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Susan Bal, Myo Htut, Omar Nadeem et al. · Blood · Sep 3, 2026 · PMID 42233419 pubmed
- DERIVEDBal S, Htut M, Nadeem O, Anderson LD Jr, Gregory T, Kocoglu MH, Rossi AC, Martin T, Egan DN, Costa LJ, Hu H, Chen J, Li S, Kelly LM, Sarkis N, Ziyad S, Jordahl KM, Kao WM, Kaeding AJ, Burgess MR, Berdeja JG. Arlocabtagene autoleucel: a GPRC5D-targeted CAR T-cell therapy for heavily pretreated relapsed/refractory multiple myeloma. Blood. 2026 Sep 3;148(10):1240-1250. doi: 10.1182/blood.2025030750. PMID 42233419