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Multiple MyelomaPhase 1NCT04674813

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

A Phase 1 study testing CC-95266, Fludarabine and Cyclophosphamide in people with Multiple Myeloma, run by Juno Therapeutics, a Subsidiary of Celgene at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
CC-95266, Fludarabine and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
10 sitesUnited States
Study dates
24 Feb 2021to 22 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • Measurable disease
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Local Institution - 008

    Baltimore, Maryland, 21201

  • Local Institution - 005

    Birmingham, Alabama, 10016

  • Local Institution - 010

    Boston, Massachusetts, 02215

  • Local Institution - 006

    Dallas, Texas, 75390

  • Local Institution - 002

    Denver, Colorado, 80218

  • Local Institution - 009

    Duarte, California, 91010-301

  • Local Institution - 001

    Nashville, Tennessee, 37203

  • Local Institution - 011

    New York, New York, 10029

  • Local Institution - 012

    San Francisco, California, 94143

  • Local Institution - 003

    Seattle, Washington, 98104

Other trials in United States

About this study

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

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).

Being tested
CC-95266, Fludarabine, Cyclophosphamide, Bendamustine
Keywords
CC-95266, Multiple Myeloma, Relapsed and/or Refractory
Medical subject headings
Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04674813
Study groupRoleWhat they receive
Administration of CC-95266ExperimentalNot described
Receives: Drug: CC-95266; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Bendamustine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Adverse Events (AEs)

    Measured: Up to 2 years after CC-95266 infusion

  2. Number of participants with significant laboratory abnormalities

    Measured: Up to 2 years after CC-95266 infusion

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

    Measured: Up to 2 years after CC-95266 infusion

  4. Maximum Tolerated Dose (MTD)

    Measured: Up to 2 years after CC-95266 infusion

  5. Recommended Phase 2 Dose (RP2D)

    Measured: Up to 2 years after CC-95266 infusion

Secondary outcomes (12)

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

    Measured: Up to 2 years after CC-95266 infusion

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

    Measured: Up to 2 years after CC-95266 infusion

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

    Measured: Up to 2 years after CC-95266 infusion

  4. Overall response rate (ORR)

    Measured: Up to 2 years after CC-95266 infusion

  5. Complete response rate (CRR)

    Measured: Up to 2 years after CC-95266 infusion

  6. Very good partial response (VGPR) or better

    Measured: Up to 2 years after CC-95266 infusion

  7. Duration of response (DOR)

    Measured: Up to 2 years after CC-95266 infusion

  8. Duration of complete response (DOCR)

    Measured: Up to 2 years after CC-95266 infusion

  9. Time to response (TTR)

    Measured: Up to 2 years after CC-95266 infusion

  10. Time to complete response (TTCR)

    Measured: Up to 2 years after CC-95266 infusion

  11. Progression-free survival (PFS)

    Measured: Up to 2 years after CC-95266 infusion

  12. Overall survival (OS)

    Measured: Up to 2 years after CC-95266 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2020
  2. Study start24 Feb 2021
  3. Primary completion22 Dec 2025
  4. Study completion22 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04674813
Sponsor's protocol ID
CC-95266-MM-001
Other IDs
U1111-1260-4921
Status last verified
Feb 2026
First submitted
14 Dec 2020
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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/

Publications

  • Bal S, Htut M, Nadeem O, Anderson LD Jr, Gregory T, Kocoglu MH, Rossi AC, Martin T, Egan DN, Costa LJ, Hu H, Chen J, Li S, Kelly LM, Sarkis N, Ziyad S, Jordahl KM, Kao WM, Kaeding AJ, Burgess MR, Berdeja JG. Arlocabtagene autoleucel: a GPRC5D-targeted CAR T-cell therapy for heavily pretreated relapsed/refractory multiple myeloma. Blood. 2026 Sep 3;148(10):1240-1250. doi: 10.1182/blood.2025030750.

    PubMed 42233419

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CC-95266, Fludarabine and Cyclophosphamide in people with Multiple Myeloma, run by Juno Therapeutics, a Subsidiary of Celgene at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Adverse Events (AEs) (time frame: Up to 2 years after CC-95266 infusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04674813, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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