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

Phase 1

Active, not recruiting

• Conditions: Multiple Myeloma
• Interventions: Drug: CC-95266; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Bendamustine

• Registration Number: NCT04674813
• Lead Sponsor: Juno Therapeutics, a Subsidiary of Celgene

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-14
• Study First Submitted QC: 2020-12-14
• Study First Posted: 2020-12-19
• Study Start: 2021-02-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26
• Primary Completion: 2025-06-07
• Study Completion: 2025-06-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of CC-95266	Cyclophosphamide	-
Administration of CC-95266	Bendamustine	-
Administration of CC-95266	CC-95266	-
Administration of CC-95266	Fludarabine	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Overall survival (OS)	Up to 2 years after CC-95266 infusion
Progression-free survival (PFS)	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

Trial Locations

Locations (10)

Local Institution - 008; 🇺🇸 Baltimore, Maryland, United States

Local Institution - 009; 🇺🇸 Duarte, California, United States

Local Institution - 011; 🇺🇸 New York, New York, United States

Local Institution - 002; 🇺🇸 Denver, Colorado, United States

Local Institution - 003; 🇺🇸 Seattle, Washington, United States

Local Institution - 005; 🇺🇸 Birmingham, Alabama, United States

Local Institution - 012; 🇺🇸 San Francisco, California, United States

Local Institution - 010; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 001; 🇺🇸 Nashville, Tennessee, United States

Local Institution - 006; 🇺🇸 Dallas, Texas, United States