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

Overview

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.

SparkCures ID 1081
Trial Phase Phase 1
Enrollment 80 Patients
Treatments
Tags
Trial Sponsors
  • Juno Therapeutics, a Subsidiary of Celgene
NCT Identifier

NCT04394650

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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:
    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

US Trial Locations

Accepting Patients

The following is a listing of trial locations that are open and accepting patients.

Not Currently Accepting Patients

The following is a listing of trial locations that are not currently open and accepting patients.

Verified Memorial Sloan Kettering Cancer Center

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Mayo Clinic (Rochester)

Rochester, MN

Alabama
Arizona
California
Illinois
Kansas
Minnesota
Mayo Clinic (Rochester)

Rochester, MN

New York
Verified Memorial Sloan Kettering Cancer Center

SparkCures Verified Accurate, up-to-date information. Learn more


North Carolina
Texas

Resources

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