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CompletedNCT04674813Updated Feb 9, 2026

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

A Phase 1 interventional study of CC-95266 and Fludarabine in Multiple Myeloma, sponsored by Juno Therapeutics, a Subsidiary of Celgene. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Juno Therapeutics, a Subsidiary of Celgene · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
130
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Multiple Myeloma

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Keywords

  • CC-95266
  • Multiple Myeloma
  • Relapsed and/or Refractory
03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 744 are open to participants now.

This study's enrollment of 130 is above the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

Juno Therapeutics, a Subsidiary of Celgene is the lead sponsor of 11 studies on the registry; 1 is open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Administration of CC-95266

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

Interventions

  • DrugCC-95266

    Specified dose on specified days

  • DrugFludarabine

    Specified dose on specified days

  • DrugCyclophosphamide

    Specified dose on specified days

  • DrugBendamustine

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to 2 years after CC-95266 infusion

  2. Number of participants with significant laboratory abnormalities

    Time frame: Up to 2 years after CC-95266 infusion

  3. Number of participants with Dose Limiting Toxicities (DLTs)

    Time frame: Up to 2 years after CC-95266 infusion

  4. Maximum Tolerated Dose (MTD)

    Time frame: Up to 2 years after CC-95266 infusion

  5. Recommended Phase 2 Dose (RP2D)

    Time frame: Up to 2 years after CC-95266 infusion

Secondary outcomes

  1. Pharmacokinetics - Maximum plasma concentration of drug (Cmax)

    Time frame: Up to 2 years after CC-95266 infusion

  2. Pharmacokinetics - Time to peak (maximum) serum concentration (tmax)

    Time frame: Up to 2 years after CC-95266 infusion

  3. Pharmacokinetics - Area under the curve for days 1-29 after CC-95266 infusion (AUC1-29)

    Time frame: Up to 2 years after CC-95266 infusion

  4. Overall response rate (ORR)

    Time frame: Up to 2 years after CC-95266 infusion

  5. Complete response rate (CRR)

    Time frame: Up to 2 years after CC-95266 infusion

  6. Very good partial response (VGPR) or better

    Time frame: Up to 2 years after CC-95266 infusion

  7. Duration of response (DOR)

    Time frame: Up to 2 years after CC-95266 infusion

  8. Duration of complete response (DOCR)

    Time frame: Up to 2 years after CC-95266 infusion

  9. Time to response (TTR)

    Time frame: Up to 2 years after CC-95266 infusion

  10. Time to complete response (TTCR)

    Time frame: Up to 2 years after CC-95266 infusion

  11. Progression-free survival (PFS)

    Time frame: Up to 2 years after CC-95266 infusion

  12. Overall survival (OS)

    Time frame: Up to 2 years after CC-95266 infusion

07

Study locations

10 sites
  • Local Institution - 005
    Birmingham, Alabama 10016, United States
  • Local Institution - 009
    Duarte, California 91010-301, United States
  • Local Institution - 012
    San Francisco, California 94143, United States
  • Local Institution - 002
    Denver, Colorado 80218, United States
  • Local Institution - 008
    Baltimore, Maryland 21201, United States
  • Local Institution - 010
    Boston, Massachusetts 02215, United States
  • Local Institution - 011
    New York, New York 10029, United States
  • Local Institution - 001
    Nashville, Tennessee 37203, United States
  • Local Institution - 006
    Dallas, Texas 75390, United States
  • Local Institution - 003
    Seattle, Washington 98104, United States
08

References and documents

Individual participant data

Plan to share: Yes — Information relating to our policy on data sharing and the process for requesting data can be found at the following link: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

Supporting information: Study protocol, Sap, Icf, Csr, Analytic code

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04674813
Lead sponsor
Juno Therapeutics, a Subsidiary of Celgene
Responsible party
Sponsor
First posted
Dec 19, 2020
Start date
Feb 24, 2021
Primary completion
Dec 22, 2025
Completion
Dec 22, 2025
Last update
Feb 9, 2026

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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