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

Sponsor
Juno Therapeutics, a Subsidiary of Celgene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04674813
Collaborator
(none)
77
Enrollment
9
Locations
1
Arm
51.3
Anticipated Duration (Months)
8.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1, multicenter, open label, study of CC-95266 in subjects with relapsed and/or refractory multiple myeloma. The study will consist of two parts: dose escalation (Part A) and dose expansion (Part B).

The dose escalation (Part A) of the study will evaluate the safety and tolerability of increasing doses of CC-95266 in a single administration to establish a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D), and the dose expansion (Part B) of the study will further evaluate the safety, pharmacokinetics (PK)/ pharmacodynamics (PD), and efficacy of CC-95266 at the RP2D.

Condition or DiseaseIntervention/TreatmentPhase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
77 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Multicenter, Open-Label Study of CC-95266 in Subjects With Relapsed and/or Refractory Multiple Myeloma
Actual Study Start Date :
Feb 24, 2021
Anticipated Primary Completion Date :
Jun 3, 2025
Anticipated Study Completion Date :
Jun 3, 2025

Arms and Interventions

ArmIntervention/Treatment
Experimental: Administration of CC-95266

Subjects will receive CC-95266 after completion of lymphodepleting (LD) chemotherapy (fludarabine and cyclophosphamide)

Drug: CC-95266
IV

Drug: Fludarabine
IV

Drug: Cyclophosphamide
IV

Outcome Measures

Primary Outcome Measures

  1. Adverse Events (AEs) [Up to 2 years after CC-95266 infusion]

    An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

  2. Maximum Tolerated Dose (MTD) [Up to 2 years after CC-95266 infusion]

    MTD is defined as the dose level that can be given such that the estimated DLT probability is closest to approximately 30%

  3. Recommended Phase 2 Dose (RP2D) [Up to 2 years after CC-95266 infusion]

    RP2D is defined as the dose recommended for further investigation in a Phase 2 study

Secondary Outcome Measures

  1. Pharmacokinetics - Cmax [Up to 2 years after CC-95266 infusion]

    Cmax is defined as maximum plasma concentration of drug

  2. Pharmacokinetics - tmax [Up to 2 years after CC-95266 infusion]

    tmax is defined as time to peak (maximum) serum concentration

  3. Pharmacokinetics - AUC(1-29) [Up to 2 years after CC-95266 infusion]

    AUC(1-29) is defined as area under the curve for days 1-29 after CC-95266 infusion

  4. Overall response rate (ORR) [Up to 2 years after CC-95266 infusion]

    ORR is defined as proportion of subjects achieving sCR, CR, VGPR, or PR

  5. Complete response rate (CRR) [Up to 2 years after CC-95266 infusion]

    CRR is defined as proportion of subjects with sCR or CR

  6. Duration of response (DOR) [Up to 2 years after CC-95266 infusion]

    DOR is defined as the time from first response (sCR, CR, VGPR, or PR) to PD or death

  7. Duration of complete response (DOCR) [Up to 2 years after CC-95266 infusion]

    DOCR is defined as a best overall response of sCR or CR, time from first response (sCR, CR, VGPR, or PR) to the first documentation of PD or death

  8. Time to response (TTR) [Up to 2 years after CC-95266 infusion]

    TTR is defined as time from CC-95266 infusion to the first documentation of response (sCR, CR, VGPR, or PR)

  9. Time to complete response (TTCR) [Up to 2 years after CC-95266 infusion]

    TTCR is defined as time from CC-95266 infusion to the first documentation of sCR or CR

  10. Progression-free survival (PFS) [Up to 2 years after CC-95266 infusion]

    PFS is defined as time from CC-95266 infusion to the first documentation of PD, or death from any cause, whichever occurs first

  11. Overall survival (OS) [Up to 2 years after CC-95266 infusion]

    OS is defined as time from CC-95266 infusion to death

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Age ≥ 18 years.

  2. Signed written informed consent prior to any study procedure.

  3. Subject has a diagnosis of multiple myeloma with relapsed and/or refractory disease. Subjects must have documented progressive disease on or within 12 months of completing treatment with the last anti-myeloma treatment regimen, except for subjects with cellular therapy (eg, CAR T-cell therapy) as their last treatment, who may enroll beyond 12 months.

  4. Subjects must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without HSCT and with or without maintenance therapy is considered one regimen), including:

  • Autologous stem cell transplant

  • A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination

  • Anti-CD38 (eg, daratumumab), either alone or combination

  1. Measurable disease

  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

  3. Adequate organ function

Exclusion Criteria:
  1. Known active or history of central nervous system (CNS) involvement of MM

  2. Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis

  3. Uncontrolled or active infection

  4. Active autoimmune disease requiring immunosuppressive therapy

  5. History or presence of clinically significant CNS pathology such as seizure disorder, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1University of Alabama BirminghamBirminghamAlabamaUnited States10016
2City of HopeDuarteCaliforniaUnited States91010-301
3Colorado Blood Cancer InstituteDenverColoradoUnited States80218
4University of Maryland - Greenebaum Comprehensive Cancer CenterBaltimoreMarylandUnited States21201
5Dana Farber Cancer InstituteBostonMassachusettsUnited States02115
6Icahn School of Medicine at Mount Sinai Medical CenterNew YorkNew YorkUnited States10029
7Sarah Cannon Research Institute Center for Blood CancersNashvilleTennesseeUnited States37203
8Southwestern Medical Center- Harold C Simmons Comprehensive Cancer CenterDallasTexasUnited States75390
9Swedish Cancer InstituteSeattleWashingtonUnited States98104

Sponsors and Collaborators

  • Juno Therapeutics, a Subsidiary of Celgene

Investigators

  • Study Director: Allison Kaeding, MD, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Juno Therapeutics, a Subsidiary of Celgene
ClinicalTrials.gov Identifier:
NCT04674813
Other Study ID Numbers:
  • CC-95266-MM-001
  • U1111-1260-4921
First Posted:
Dec 19, 2020
Last Update Posted:
Sep 23, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Juno Therapeutics, a Subsidiary of Celgene
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 23, 2021