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

Not Recruiting

Trial ID: NCT04394650

Purpose

This is a Phase 1, multicenter, open-label study of CC-98633, BCMA-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, in participants 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(s); 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(s).

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

Stanford Investigator(s)

Michaela Liedtke
Michaela Liedtke

Associate Professor of Medicine (Hematology)

Surbhi Sidana, MD
Surbhi Sidana, MD

Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Eligibility


Inclusion Criteria:

   1. Age ≥ 18 years.

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

   3. Relapsed and/or refractory multiple myeloma (MM).

      1. Subjects must have documented progressive disease as per International Myeloma
      Working Group (IMWG) criteria during or within 12 months of completing treatment
      with the last anti-myeloma treatment regimen before study entry. Also, subjects
      with confirmed progressive disease within 6 months prior to start of Screening
      and who are refractory (or non-responsive) to their most recent anti-myeloma
      treatment regimen afterwards will be also eligible.

      2. Part A and Part B Cohort A: Subjects must have confirmed at least 3 prior
      antimyeloma treatment regimens.

      3. Part B Cohort B only: Subjects must have received at least 1 but no greater than
      3 prior antimyeloma treatment regimens, including a proteasome inhibitor and
      immunomodulatory agent.

      4. Subjects must have previously received all of the following therapies:

   i) Autologous stem cell transplant ii) A regimen that included an immunomodulatory
   agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg,
   bortezomib, carfilzomib, ixazomib), either alone or combination iii) Anti-CD38 (eg,
   daratumumab), either alone or combination Subjects in Cohort B do not require prior
   anti-CD38 antibody therapy.

   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. Part A and Part B Cohort A only: 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

Intervention(s):

biological: CC-98633

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Reneth T. Inthasack
650-723-0646

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