OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorOriCell Therapeutics Co., Ltd.
About this trial
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of R/RMM according to the IMWG criteria;
Expected survival period is >12 weeks;
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 or 2 at the time of ICF signature;
Serum M protein >5 g/L;
Disqualifiers
Smoldering myeloma (asymptomatic)
Multiple myeloma with only extramedullary lesions;
Plasma cell leukemia;
Concurrent amyloidosis;
Trial design
Design model
Single group
Treatments tested in this trial
OriCAR-017
Biological/VaccineGPCRC5D-directed chimeric antigen receptor modified T cells
Treatment groups
83 Participants
are divided into 1 treatment groupGroup A: OriCAR-017 ( GPCRC5D-directed chimeric antigen receptor modified T cells )Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 days2
Dose-limiting toxicity (DLT)
tolerability
Time frame
Up to 28 daysSecondary outcomes
1
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 Years2
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 years3
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 years4
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 yearsSponsors and contacts
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Source ClinicalTrials.gov