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

Juno Therapeutics, a Subsidiary of Celgene10 sites in 1 country130 target enrollmentFebruary 24, 2021

ConditionsMultiple Myeloma

InterventionsCC-95266 Fludarabine Cyclophosphamide Bendamustine

DrugsCC-95266 Fludarabine Cyclophosphamide Bendamustine

Overview

Phase: Phase 1
Intervention: CC-95266
Conditions: Multiple Myeloma
Sponsor: Juno Therapeutics, a Subsidiary of Celgene
Enrollment: 130
Locations: 10
Primary Endpoint: Number of participants with Adverse Events (AEs)
Status: Completed
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

February 24, 2021

End Date

December 22, 2025

Last Updated

2 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Juno Therapeutics, a Subsidiary of Celgene

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Administration of CC-95266

Intervention: CC-95266

Administration of CC-95266

Intervention: Fludarabine

Administration of CC-95266

Intervention: Cyclophosphamide

Administration of CC-95266

Intervention: Bendamustine