Multiple Myeloma Clinical Trial
A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
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).
Age ≥ 18 years.
Signed written informed consent prior to any study procedure.
Relapsed and/or refractory multiple myeloma (MM).
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.
Part A and Part B Cohort A: Subjects must have confirmed at least 3 prior antimyeloma treatment regimens.
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.
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.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function
Known active or history of central nervous system (CNS) involvement of MM
Active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes) syndrome, or clinically significant amyloidosis
Prior treatment with CAR T-cell or another genetically modified T-cell therapy
Part A and Part B Cohort A only: Prior treatment with investigational therapy directed at BCMA
Uncontrolled or active infection
Active autoimmune disease requiring immunosuppressive therapy
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
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There are 11 Locations for this study
Birmingham Alabama, 35233, United States
Phoenix Arizona, 85054, United States
Stanford California, 94305, United States
Chicago Illinois, 60637, United States
Westwood Kansas, 66205, United States
Rochester Minnesota, 55905, United States
Buffalo New York, 14263, United States
New York New York, 10029, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Dallas Texas, 75390, United States
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