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Completed

NCT Number: NCT04674813

A Study of CC-95266 in Participants 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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 005, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CC-95266

Drug

Specified dose on specified days

Fludarabine

Drug

Specified dose on specified days

Cyclophosphamide

Drug

Specified dose on specified days

Bendamustine

Drug

Specified dose on specified days

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

Sponsors and collaborators

Lead sponsor

Juno Therapeutics, a Subsidiary of Celgene

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Dec 19, 2020
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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