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

  • Clinicaltrials.gov identifier

    NCT04394650

  • Recruitment Status

    Recruiting

  • First Posted

    May 19, 2020

  • Last update posted

    September 8, 2021

Study Description

Brief summary:

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.

  • Condition or Disease:Multiple Myeloma
  • Intervention/Treatment: Biological: CC-98633
  • Phase: Phase 1

Detailed Description

N/A

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 80 participants
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • 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
  • Actual Study Start Date: August 2020
  • Estimated Primary Completion Date: November 2023
  • Estimated Study Completion Date: November 2023

Arms and interventions

Arm Intervention/treatment
Experimental: CC-98633
Subjects will receive CC-98633 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide).
Biological: CC-98633
Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CC 98633. During CC 98633 production, subjects may receive bridging chemotherapy for disease control. Upon successful generation of CC 98633 product, subjects will receive treatment with CC 98633 therapy. Study treatment will include lymphodepleting chemotherapy followed by one dose of CC-98633 administered by intravenous (IV) injection.

Outcome Measures

  • Primary Outcome Measures: 1. Adverse Events (AEs) [ Time Frame: From the time of informed consent and follow up to 2 years after infusion of CC-98633: ]
    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: 1. Overall survival (OS) [ Time Frame: Up to 2 years after CC-98633 infusion ]
    Time from CC-98633 infusion to death
  • 2. Overall Response Rate (ORR) [ Time Frame: Up to 2 years after CC-98633 infusion ]
    The proportion of subjects with a partial response (PR) or better by the IMWG criteria.
  • 3. Complete Response (CR) Rate [ Time Frame: Up to 2 years after CC-99633 infusion ]
    The proportion of subjects achieving stringent CR or CR.
  • 4. Duration of response (DOR) [ Time Frame: Up to 2 years after CC-98633 infusion ]
    The time from first response (sCR, CR, VGPR, or PR) to progressive disease (PD) or death.
  • 5. Time to response (TTR) [ Time Frame: Up to 2 years after CC-98633 infusion ]
    Time from CC-98633 infusion to the first documentation of response (sCR, CR, VGPR or PR).
  • 6. Time to complete response (TTCR) [ Time Frame: Up to 2 years after CC-98633 infusion ]
    Time from CC-98633 infusion to the first documentation of sCR or CR
  • 7. Progression free survival (PFS) [ Time Frame: Up to 2 years after CC-98633 infusion ]
    Time from CC-98633 infusion to the first documentation of PD, or death from any cause, whichever occurs first
  • 8. Pharmacokinetics - maximum serum concentration (Cmax) [ Time Frame: Up to 2 years after CC-98633 infusion ]
    Maximum blood concentration
  • 9. Pharmacokinetics -time to peak serum concentration (tmax) [ Time Frame: Up to 2 years after CC-98633 infusion ]
    Time to peak (maximum) blood concentration
  • 10. Pharmacokinetics - Area under curve (AUC) [ Time Frame: Up to 2 years after CC-98633 infusion ]
    Area under the curve
  • 11. Very good partial response (VGPR) or better [ Time Frame: Up to 2 years after CC-98633 infusion ]
    Is define as proportion of subjects achieving sCR, CR, or VGPR

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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. Subjects must have documented progressive disease during or within 12 months of completing treatment with the last anti-myeloma treatment regimen before study entry. Also, subjects with documented evidence of progressive disease within the previous 6 months and who are refractory or nonresponsive to their most recent anti-myeloma treatment regimen afterwards will be also eligible. Subjects must have previously received all of the 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

Contacts and Locations

Contacts

Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations

United States, Alabama
University of Alabama at Birmingham Hospital
Birmingham

United States, Arizona
Mayo Clinic
Phoenix

United States, California
Stanford Cancer Center
Stanford

United States, Illinois
University of Chicago Medicine
Chicago

United States, Kansas
University of Kansas Hospital
Westwood

United States, Minnesota
Mayo Clinic
Rochester

United States, New York
Roswell Park Cancer Institute
Buffalo

United States, New York
Icahn School of Medicine at Mount Sinai
New York

United States, New York
Memorial Sloan Kettering Cancer Center
New York

United States, North Carolina
Levine Cancer Institute
Charlotte

United States, Texas
UT Southwestern Medical Center
Dallas

Sponsors and Collaborators

Juno Therapeutics, a Subsidiary of Celgene

Investigators

Study Director: Ashley Koegel, MD Early Clinical Development

More Information

  • Responsible Party: Juno Therapeutics, a Subsidiary of Celgene
  • ClinicalTrials.gov Identifier: NCT04394650 History of Changes
  • Other Study ID Numbers: CC-98633-MM-001, U1111-1251-3435
  • First Posted: May 19, 2020 Key Record Dates
  • Last Update Posted: September 8, 2021
  • Last Verified: September 2021
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: Yes
  • Plan Description: 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/
  • Supporting Materials: Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF), Clinical Study Report (CSR), Analytic Code
  • Time Frame: See Plan Description
  • Access Criteria: See Plan Description
  • URL: https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/
  • 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: BCMA CAR-T
    BCMA CART
    CART
    CAR-T
    BCMA
    CC-98633
    Myeloma Multiple
    Myeloma
    Multiple Myeloma
  • Additional relevant MeSH terms: Neoplasms, Plasma Cell Multiple Myeloma