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

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

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).

Key facts

Study ID

NCT04674813

Run by

Juno Therapeutics, a Subsidiary of Celgene

People needed

130

Starts

2021-02-24

Expected to finish

2025-12-22

Last updated by the study team

2026-02-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Local Institution - 005 — Birmingham, Alabama, United States
• Local Institution - 009 — Duarte, California, United States
• Local Institution - 012 — San Francisco, California, United States
• Local Institution - 002 — Denver, Colorado, United States
• Local Institution - 008 — Baltimore, Maryland, United States
• Local Institution - 010 — Boston, Massachusetts, United States
• Local Institution - 011 — New York, New York, United States
• Local Institution - 001 — Nashville, Tennessee, United States
• Local Institution - 006 — Dallas, Texas, United States
• Local Institution - 003 — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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