Status:
COMPLETED
A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants With Relapsed and/or Refractory Multiple Myeloma
Lead Sponsor:
Juno Therapeutics, a Subsidiary of Celgene
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2024
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04394650
Start Date
August 18 2020
End Date
July 3 2024
Last Update
July 26 2024
Active Locations (11)
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1
Local Institution - 103
Birmingham, Alabama, United States, 35233
2
Local Institution - 111
Phoenix, Arizona, United States, 85054
3
Local Institution - 110
Stanford, California, United States, 94305
4
Local Institution - 107
Chicago, Illinois, United States, 60637