Clinical Trials /

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

NCT04674813

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: CC-95266-MM-001
  • SECONDARY ID: U1111-1260-4921
  • NCT ID: NCT04674813

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
CC-95266Administration of CC-95266
FludarabineAdministration of CC-95266
CyclophosphamideAdministration of CC-95266

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Administration of CC-95266ExperimentalSubjects will receive CC-95266 after completion of lymphodepleting (LD) chemotherapy (fludarabine and cyclophosphamide)
  • CC-95266
  • Fludarabine
  • Cyclophosphamide

Eligibility Criteria

        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

          5. Measurable disease

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

          7. 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Adverse Events (AEs)
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description: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.

Secondary Outcome Measures

Measure:Pharmacokinetics - Cmax
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description:Cmax is defined as maximum plasma concentration of drug
Measure:Pharmacokinetics - tmax
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description:tmax is defined as time to peak (maximum) serum concentration
Measure:Pharmacokinetics - AUC(1-29)
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description:AUC(1-29) is defined as area under the curve for days 1-29 after CC-95266 infusion
Measure:Overall response rate (ORR)
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description:ORR is defined as proportion of subjects achieving sCR, CR, VGPR, or PR
Measure:Complete response rate (CRR)
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description:CRR is defined as proportion of subjects with sCR or CR
Measure:Duration of response (DOR)
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description:DOR is defined as the time from first response (sCR, CR, VGPR, or PR) to PD or death
Measure:Duration of complete response (DOCR)
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description: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
Measure:Time to response (TTR)
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description:TTR is defined as time from CC-95266 infusion to the first documentation of response (sCR, CR, VGPR, or PR)
Measure:Time to complete response (TTCR)
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description:TTCR is defined as time from CC-95266 infusion to the first documentation of sCR or CR
Measure:Progression-free survival (PFS)
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description:PFS is defined as time from CC-95266 infusion to the first documentation of PD, or death from any cause, whichever occurs first
Measure:Overall survival (OS)
Time Frame:Up to 2 years after CC-95266 infusion
Safety Issue:
Description:OS is defined as time from CC-95266 infusion to death

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Juno Therapeutics, a Subsidiary of Celgene

Trial Keywords

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

Last Updated

March 15, 2021