A Study of CC-95266 in Participants With Relapsed and/or Refractory Multiple Myeloma

Study Overview
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Brief Summary
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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).

Official Title
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A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: CC-95266
* Drug: Fludarabine
* Drug: Cyclophosphamide
* Drug: Bendamustine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Administration of CC-95266<br> | Drug: CC-95266<br>* Specified dose on specified days<br>Drug: Fludarabine<br>* Specified dose on specified days<br>Drug: Cyclophosphamide<br>* Specified dose on specified days<br>Drug: Bendamustine<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events (AEs) |  | Up to 2 years after CC-95266 infusion | 
| Number of participants with significant laboratory abnormalities |  | Up to 2 years after CC-95266 infusion | 
| Number of participants with Dose Limiting Toxicities (DLTs) |  | Up to 2 years after CC-95266 infusion | 
| Maximum Tolerated Dose (MTD) |  | Up to 2 years after CC-95266 infusion | 
| Recommended Phase 2 Dose (RP2D) |  | Up to 2 years after CC-95266 infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics - Maximum plasma concentration of drug (Cmax) |  | Up to 2 years after CC-95266 infusion | 
| Pharmacokinetics - Time to peak (maximum) serum concentration (tmax) |  | Up to 2 years after CC-95266 infusion | 
| Pharmacokinetics - Area under the curve for days 1-29 after CC-95266 infusion (AUC1-29) |  | Up to 2 years after CC-95266 infusion | 
| Overall response rate (ORR) |  | Up to 2 years after CC-95266 infusion | 
| Complete response rate (CRR) |  | Up to 2 years after CC-95266 infusion | 
| Very good partial response (VGPR) or better |  | Up to 2 years after CC-95266 infusion | 
| Duration of response (DOR) |  | Up to 2 years after CC-95266 infusion | 
| Duration of complete response (DOCR) |  | Up to 2 years after CC-95266 infusion | 
| Time to response (TTR) |  | Up to 2 years after CC-95266 infusion | 
| Time to complete response (TTCR) |  | Up to 2 years after CC-95266 infusion | 
| Progression-free survival (PFS) |  | Up to 2 years after CC-95266 infusion | 
| Overall survival (OS) |  | Up to 2 years after CC-95266 infusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CC-95266, Multiple Myeloma, Relapsed and/or Refractory