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

Summary

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.

Measurable disease
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function

Exclusion Criteria:

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT04394650

Recruitment Status:

Active, not recruiting

Sponsor:

Juno Therapeutics, a Subsidiary of Celgene

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There are 11 Locations for this study

See Locations Near You

Local Institution - 103
Birmingham Alabama, 35233, United States
University of Alabama at Birmingham Hospital
Birmingham Alabama, 35233, United States
Local Institution - 111
Phoenix Arizona, 85054, United States
Mayo Clinic
Phoenix Arizona, 85054, United States
Local Institution - 110
Stanford California, 94305, United States
Stanford Cancer Center
Stanford California, 94305, United States
Local Institution - 107
Chicago Illinois, 60637, United States
University of Chicago Medicine
Chicago Illinois, 60637, United States
University of Kansas Hospital
Westwood Kansas, 66205, United States
Local Institution - 109
Rochester Minnesota, 55905, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
Local Institution - 106
Buffalo New York, 14263, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Icahn School of Medicine at Mount Sinai
New York New York, 10029, United States
Local Institution - 104
New York New York, 10029, United States
Local Institution - 102
New York New York, 10065, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Local Institution - 108
Charlotte North Carolina, 28204, United States
Local Institution - 105
Dallas Texas, 75390, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

150

Study ID:

NCT04394650

Recruitment Status:

Active, not recruiting

Sponsor:


Juno Therapeutics, a Subsidiary of Celgene

How clear is this clinincal trial information?

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