Clinical Trials /

A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma

NCT04394650

Description:

This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in subjects with relapsed and/or refractory multiple myeloma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-98633 to establish a recommended Phase 2 dose (RP2D); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633 at the RP2D.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma
  • Official Title: A Phase I, Multi Center, Open Label Study of CC-98633, BCMA Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma

Clinical Trial IDs

  • ORG STUDY ID: CC-98633-MM-001
  • SECONDARY ID: U1111-1251-3435
  • NCT ID: NCT04394650

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
CC-98633CC-98633

Purpose

This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in subjects with relapsed and/or refractory multiple myeloma. The study will consist of 2 parts: dose-escalation (Part A) and dose-expansion (Part B). The dose-escalation part (Part A) of the study is to evaluate the safety and tolerability of increasing dose levels of CC-98633 to establish a recommended Phase 2 dose (RP2D); and the dose-expansion part (Part B) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of CC-98633 at the RP2D.

Trial Arms

NameTypeDescriptionInterventions
CC-98633ExperimentalSubjects will receive CC-98633 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide).
  • CC-98633

Eligibility Criteria

        Inclusion Criteria:

          1. Age ≥ 18 years.

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

          3. Relapsed and/or refractory multiple myeloma (MM). Subjects must have received at least
             3 prior antimyeloma treatment regimens and be refractory to the last regimen prior to
             study entry. Subjects must have previously received all of the following therapies:

             following therapies:

               1. Autologous stem cell transplant

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

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

          4. Measurable disease

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

          6. 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. Prior treatment with CAR T-cell or another genetically modified T-cell therapy

          4. Prior treatment with investigational therapy directed at BCMA

          5. Uncontrolled or active infection

          6. Active autoimmune disease requiring immunosuppressive therapy

          7. 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:From the time of informed consent and follow up to 2 years after infusion of CC-98633:
Safety Issue:
Description:incidence and severity of AEs. 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:Overall Response Rate (ORR)
Time Frame:Up to 2 years after CC-98633 infusion
Safety Issue:
Description:The proportion of subjects with a partial response (PR) or better by the IMWG criteria.
Measure:Complete Response (CR) Rate
Time Frame:Up to 2 years after CC-99633 infusion
Safety Issue:
Description:The proportion of subjects achieving stringent CR or CR.
Measure:Duration of response (DOR)
Time Frame:Up to 2 years after CC-98633 infusion
Safety Issue:
Description:The time from first response (sCR, CR, VGPR, or PR) to progressive disease (PD) or death.
Measure:Time to response (TTR)
Time Frame:Up to 2 years after CC-98633 infusion
Safety Issue:
Description:Time from CC-98633 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-98633 infusion
Safety Issue:
Description:Time from CC-98633 infusion to the first documentation of sCR or CR
Measure:Progression free survival (PFS)
Time Frame:Up to 2 years after CC-98633 infusion
Safety Issue:
Description:Time from CC-98633 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-98633 infusion
Safety Issue:
Description:Time from CC-98633 infusion to death
Measure:Pharmacokinetics - maximum serum concentration (Cmax)
Time Frame:Up to 2 years after CC-98633 infusion
Safety Issue:
Description:Maximum blood concentration
Measure:Pharmacokinetics -time to peak serum concentration (tmax)
Time Frame:Up to 2 years after CC-98633 infusion
Safety Issue:
Description:Time to peak (maximum) blood concentration
Measure:Pharmacokinetics - Area under curve (AUC)
Time Frame:Up to 2 years after CC-98633 infusion
Safety Issue:
Description:Area under the curve

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Juno Therapeutics, a Subsidiary of Celgene

Trial Keywords

  • Multiple Myeloma
  • Myeloma
  • Myeloma Multiple
  • CC-98633
  • BCMA
  • CAR-T
  • CART
  • BCMA CART
  • BCMA CAR-T

Last Updated

May 14, 2020