An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
This is a Phase I and Phase II, open-label, multi-center study to assess the safety, pharmacokinetics, and efficacy of GPRC5D directed chimeric antigen receptor modified T cells injection (OriCAR-017) in n patients with relapsed and/or refractory multiplemyeloma (R/RMM).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
83
GPCRC5D-directed chimeric antigen receptor modified T cells
The First Affiliated Hospital College of Medicine Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGBeijing GoBroad Hospital
Beijing, China
NOT_YET_RECRUITINGThe First Affiliated Hospital with Nanjing Medical University
Nanjing, China
Maximum tolerated dose of OriCAR-017-P1
The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.
Time frame: Up to 28 days
Dose-limiting toxicity (DLT)
tolerability
Time frame: Up to 28 days
Objective Response Rate
Objective response is defined as the participants with a partial response (PR) or better by the RECIST1.1 criteria.
Time frame: From date of randomization until the date of first documented progression or date of death from any cause or withdraw, whichever came first, assessed up to 2 Years
Pharmacokinetics (the number of cell copies and cell persistence duration in peripheral blood)
CAR-GPRC5D DNA in peripheral blood detected by q-PCR at each visit after infusion
Time frame: From date of randomization until the date of first documented progression or date of death from any cause or withdraw, whichever came first, assessed up to 2 years
Antitumor efficacy-Progression-free survival (PFS)
The period from the day when the subject receives the infusion of cells to the first recorded tumor progression
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Antitumor efficacy-Duration of response (DOR)
The period from the first evaluation of sCR or CR or VGPR or PR or MR to the first evaluation of PD or death of any cause
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
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Tongji Hospital of Tongji University
Shanghai, China
NOT_YET_RECRUITINGUnion Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
RECRUITINGLong term survival follow up
The period from randomization until the date of death
Time frame: From date of randomization until the date of first documented date of death from any cause, assessed up to 15 years