Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04394650
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Juno Therapeutics, a Subsidiary of Celgene

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 Intervention/treatment Phase
Multiple Myeloma Biological: CC-98633 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
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 18, 2020
Estimated Primary Completion Date : January 7, 2025
Estimated Study Completion Date : January 7, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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.





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 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.

  2. Complete Response (CR) Rate [ Time Frame: Up to 2 years after CC-99633 infusion ]
    The proportion of subjects achieving stringent CR or CR.

  3. 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.

  4. 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).

  5. 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

  6. 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

  7. Overall survival (OS) [ Time Frame: Up to 2 years after CC-98633 infusion ]
    Time from CC-98633 infusion to death

  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394650


Contacts
Layout table for location contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham Hospital Recruiting
Birmingham, Alabama, United States, 35233
United States, Arizona
Mayo Clinic Not yet recruiting
Phoenix, Arizona, United States, 85054
United States, California
Stanford Cancer Center Not yet recruiting
Stanford, California, United States, 94305
United States, Illinois
University of Chicago Medicine Not yet recruiting
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas Hospital Recruiting
Westwood, Kansas, United States, 66205-2003
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
United States, Texas
UT Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Juno Therapeutics, a Subsidiary of Celgene
Investigators
Layout table for investigator information
Study Director: Ashley Koegel, MD Early Clinical Development
Layout table for additonal information
Responsible Party: Juno Therapeutics, a Subsidiary of Celgene
ClinicalTrials.gov Identifier: NCT04394650    
Other Study ID Numbers: CC-98633-MM-001
U1111-1251-3435 ( Other Identifier: WHO )
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
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/

Layout table for additional information
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:
Multiple Myeloma
Myeloma
Myeloma Multiple
CC-98633
BCMA
CAR-T
CART
BCMA CART
BCMA CAR-T
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases