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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Alabama at Birmingham Hospital
Birmingham, Alabama 35233

More Details

Status
Recruiting
Sponsor
Juno Therapeutics, a Subsidiary of Celgene

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.