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

NCT04674813 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: CC-95266-MM-001U1111-1260-4921
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 10

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).

Conditions

Multiple Myeloma

Keywords

CC-95266; Multiple Myeloma; Relapsed and/or Refractory

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (12)

• 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

Study Arms (1)

Administration of CC-95266

EXPERIMENTAL

Drug: CC-95266; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Bendamustine

Interventions

CC-95266 DRUG

Specified dose on specified days

Administration of CC-95266

Fludarabine DRUG

Specified dose on specified days

Administration of CC-95266

Cyclophosphamide DRUG

Specified dose on specified days

Administration of CC-95266

Bendamustine DRUG

Specified dose on specified days

Administration of CC-95266

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Juno Therapeutics, a Subsidiary of Celgene: lead

Study Sites (10)

Local Institution - 005

Birmingham, Alabama, 10016, United States

Location

Local Institution - 009

Duarte, California, 91010-301, United States

Location

Local Institution - 012

San Francisco, California, 94143, United States

Location

Local Institution - 002

Denver, Colorado, 80218, United States

Location

Local Institution - 008

Baltimore, Maryland, 21201, United States

Location

Local Institution - 010

Boston, Massachusetts, 02215, United States

Location

Local Institution - 011

New York, New York, 10029, United States

Location

Local Institution - 001

Nashville, Tennessee, 37203, United States

Location

Local Institution - 006

Dallas, Texas, 75390, United States

Location

Local Institution - 003

Seattle, Washington, 98104, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Multiple Myeloma

Interventions

fludarabine; Cyclophosphamide; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: December 19, 2020
• Study Start: February 24, 2021
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (10)