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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
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.
Local Institution - 103
Birmingham, Alabama, United States
Local Institution - 111
Phoenix, Arizona, United States
Local Institution - 110
Stanford, California, United States
Local Institution - 107
Chicago, Illinois, United States
Local Institution - 101
Westwood, Kansas, United States
Local Institution - 109
Rochester, Minnesota, United States
Local Institution - 106
Buffalo, New York, United States
Local Institution - 104
New York, New York, United States
Local Institution - 102
New York, New York, United States
Local Institution - 108
Charlotte, North Carolina, United States
...and 1 more locations
Adverse Events (AEs)
incidence and severity of AEs. An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a subject during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the subject's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.
Time frame: From the time of informed consent and follow up to 2 years after infusion of CC-98633:
Overall Response Rate (ORR)
The proportion of subjects with a partial response (PR) or better by the IMWG criteria.
Time frame: Up to 2 years after CC-98633 infusion
Complete Response (CR) Rate
The proportion of subjects achieving stringent CR or CR.
Time frame: Up to 2 years after CC-99633 infusion
Duration of response (DOR)
The time from first response (sCR, CR, VGPR, or PR) to progressive disease (PD) or death.
Time frame: Up to 2 years after CC-98633 infusion
Time to response (TTR)
Time from CC-98633 infusion to the first documentation of response (sCR, CR, VGPR or PR).
Time frame: Up to 2 years after CC-98633 infusion
Time to complete response (TTCR)
Time from CC-98633 infusion to the first documentation of sCR or CR
Time frame: Up to 2 years after CC-98633 infusion
Progression free survival (PFS)
Time from CC-98633 infusion to the first documentation of PD, or death from any cause, whichever occurs first
Time frame: Up to 2 years after CC-98633 infusion
Overall survival (OS)
Time from CC-98633 infusion to death
Time frame: Up to 2 years after CC-98633 infusion
Pharmacokinetics - maximum serum concentration (Cmax)
Maximum blood concentration
Time frame: Up to 2 years after CC-98633 infusion
Pharmacokinetics -time to peak serum concentration (tmax)
Time to peak (maximum) blood concentration
Time frame: Up to 2 years after CC-98633 infusion
Pharmacokinetics - Area under curve (AUC)
Area under the curve
Time frame: Up to 2 years after CC-98633 infusion
Very good partial response (VGPR) or better
Is define as proportion of subjects achieving sCR, CR, or VGPR
Time frame: Up to 2 years after CC-98633 infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.