A Study of CC-98633, BCMA-targeted Chimeric Antigen Receptor (CAR) T Cells, in Subjects With Relapsed and/or Refractory Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT04394650|
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : October 22, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Biological: CC-98633||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I, Multi Center, 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|
|Actual Study Start Date :||August 18, 2020|
|Estimated Primary Completion Date :||January 7, 2025|
|Estimated Study Completion Date :||January 7, 2025|
Subjects will receive CC-98633 following 3 consecutive doses of lymphodepleting chemotherapy (fludarabine and cyclophosphamide).
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.
- Adverse Events (AEs) [ Time Frame: From the time of informed consent and follow up to 2 years after infusion of CC-98633: ]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.
- Overall Response Rate (ORR) [ Time Frame: Up to 2 years after CC-98633 infusion ]The proportion of subjects with a partial response (PR) or better by the IMWG criteria.
- Complete Response (CR) Rate [ Time Frame: Up to 2 years after CC-99633 infusion ]The proportion of subjects achieving stringent CR or CR.
- Duration of response (DOR) [ Time Frame: Up to 2 years after CC-98633 infusion ]The time from first response (sCR, CR, VGPR, or PR) to progressive disease (PD) or death.
- Time to response (TTR) [ Time Frame: Up to 2 years after CC-98633 infusion ]Time from CC-98633 infusion to the first documentation of response (sCR, CR, VGPR or PR).
- Time to complete response (TTCR) [ Time Frame: Up to 2 years after CC-98633 infusion ]Time from CC-98633 infusion to the first documentation of sCR or CR
- Progression free survival (PFS) [ Time Frame: Up to 2 years after CC-98633 infusion ]Time from CC-98633 infusion to the first documentation of PD, or death from any cause, whichever occurs first
- Overall survival (OS) [ Time Frame: Up to 2 years after CC-98633 infusion ]Time from CC-98633 infusion to death
- Pharmacokinetics - maximum serum concentration (Cmax) [ Time Frame: Up to 2 years after CC-98633 infusion ]Maximum blood concentration
- Pharmacokinetics -time to peak serum concentration (tmax) [ Time Frame: Up to 2 years after CC-98633 infusion ]Time to peak (maximum) blood concentration
- Pharmacokinetics - Area under curve (AUC) [ Time Frame: Up to 2 years after CC-98633 infusion ]Area under the curve
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04394650
|Contact: Associate Director Clinical Trial Disclosureemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham Hospital||Recruiting|
|Birmingham, Alabama, United States, 35233|
|United States, Arizona|
|Mayo Clinic||Not yet recruiting|
|Phoenix, Arizona, United States, 85054|
|United States, California|
|Stanford Cancer Center||Not yet recruiting|
|Stanford, California, United States, 94305|
|United States, Illinois|
|University of Chicago Medicine||Not yet recruiting|
|Chicago, Illinois, United States, 60637|
|United States, Kansas|
|University of Kansas Hospital||Recruiting|
|Westwood, Kansas, United States, 66205-2003|
|United States, Minnesota|
|Mayo Clinic||Not yet recruiting|
|Rochester, Minnesota, United States, 55905|
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Icahn School of Medicine at Mount Sinai||Recruiting|
|New York, New York, United States, 10029|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|United States, North Carolina|
|Levine Cancer Institute||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|United States, Texas|
|UT Southwestern Medical Center||Not yet recruiting|
|Dallas, Texas, United States, 75390|
|Study Director:||Ashley Koegel, MD||Early Clinical Development|