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

  • STATUS
    Recruiting
  • days left to enroll
    76
  • participants needed
    80
  • sponsor
    Juno Therapeutics, a Subsidiary of Celgene
Updated on 19 February 2024
measurable disease
multiple myeloma
bortezomib
lenalidomide
carfilzomib
daratumumab
thalidomide
refractory multiple myeloma
ixazomib
pomalidomide
proteasome inhibitor
bcma
immunotherapeutic agent

Summary

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.

Details
Condition Multiple Myeloma, Multiple Myeloma, Lymphoproliferative Disorder
Age 18-100 years
Treatment CC-98633
Clinical Study IdentifierNCT04394650
SponsorJuno Therapeutics, a Subsidiary of Celgene
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years
Signed written informed consent prior to any study procedure
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
Autologous stem cell transplant
A regimen that included an immunomodulatory agent (eg, thalidomide, lenalidomide, pomalidomide) and a proteasome inhibitor (eg, bortezomib, carfilzomib, ixazomib), either alone or combination
Anti-CD38 (eg, daratumumab), either alone or combination
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
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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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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