The is a first clinical study for Oricell Therapeutics Inc. in the United States to evaluate the safety, PK, PD and preliminary efficacy of our anti-GPRC5D cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma. RIGEL Study
This is a Phase I/II, open-label multicenter study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of anti-GPRC5D CAR-T cell product (OriCAR-017) in subjects with relapsed/refractory multiple myeloma". The study will consist of a Phase I dose escalation stage involving three doses as a single IV infusion) with up to 18 evaluable subjects and a dose expansion stage with 10-15 evaluable subjects, followed by a Phase II stage with up to 48 evaluable subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
81
Anti-GPRC5D CAR-T cell product
Northside Hospital
Atlanta, Georgia, United States
RECRUITINGMaximum tolerated dose (MTD) of OriCAR-017 US-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)
A DLT is defined as any of the treatment-emergent adverse events (TEAEs; a TEAE is defined as an adverse event \[AE\] that starts on or after the first administration of study medication) condition or concomitant medications.
Time frame: Up to 28 days
Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM
Assess concentration of CAR-T cells in peripheral blood
Time frame: Up to 2 years
Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM
Assess PD markers related to CAR-T therapy in peripheral blood.
Time frame: Up to 2 years
Assessment of Duration of Response (DOR) of treatment in patients with RR/MM
DOR as assessed by Local Investigators according to the IMWG Criteria
Time frame: Up to 2 years
Progress-Free Survival (PFS) of treatment in patients with RR/MM
PFS as assessed by Local Investigators according to the IMWG Criteria
Time frame: Up to 2 years
Assessment of Overall Survival (OS) of treatment in patients with RR/MM
OS as assessed by Local Investigators according to the IMWG Criteria
Time frame: Up to 2 years
Assessment of MRD negative Rate
Proportion of subjects with MRD negative status by flow cytometry
Time frame: Up to 2 years
Assessment of Overall Response Rate (ORR)
Percentage of subjects with PR, + VGPR+ CR + strict complete response (sCR) as assessed by Local Investigator according to the IMWG criteria
Time frame: Up to 2 years
Assessment of Disease Control Rate (DCR)
Percentage of subjects with CBR (Clinical Benefit Rate) + Stable Disease as assessed by Local Investigator according to IMWG Criteria
Time frame: Up to 2 years
Assessment of Clinical Benefit Rate (CBR)
Percentage of subjects with ORR + Minimal Response by Local Investigator according to IMWG Criteria
Time frame: Up to 2 years
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