A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study
- Conditions
- Hemostatic DisordersLymphoproliferative DisordersMultiple MyelomaNeoplasmsHematologic DiseasesImmunoproliferative DisordersCardiovascular DiseasesParaproteinemiasNeoplasms, Plasma CellNeoplasms by Histologic Type
- Interventions
- Registration Number
- NCT06271252
- Lead Sponsor
- OriCell Therapeutics Co., Ltd.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 81
Capable of giving signed informed consent
Subjects aged 18 to 75 years (inclusive) at Screening (signing the ICF).
Expected survival period is >12 weeks.
Diagnosis of MM according to the IMWG criteria (2016 version).
One of the following criteria must be met:
If immunoglobulin (Ig)G type MM, then serum M protein >10 g/L; if IgA, IgD, IgE or IgM type MM, then serum M protein >5 g/L
Urine M protein level >200 mg/24 hour
If light chain type MM, then serum free light chain (sFLC) >100 mg/L and K/λ FLC ratio is abnormal.
Extramedullary lesions (>1 cm for diameter of the short axis).
For Phase I (dose-escalation) - Subjects who had received at least 3 prior lines of therapy, had previous exposure to BCMA-Ag+ therapies, and were refractory to the last line of therapy.
For Phase I (dose-expansion) and Phase II: Subjects with previous exposure to BCMA directed therapies including BCMA bispecific antibody (e.g., teclistamab), BCMA antibody directed conjugate (such as BLENREP), and BCMA-CAR-T (such as CARVYKT1TM)
Subjects with adequate hematologic, renal, hepatic, pulmonary and cardiac function.
Subject and partners willing to take and or use effective contraceptive measures until 2 years post IMP infusion.
Pregnant or breastfeeding.
Seropositive for history of human immunodeficiency virus Active Hepatitis B infection and or Hepatitis C infection
Known active or prior history of CNS involvement
History of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) caused damage to terminal organs or required systemic application of immunosuppressive or other drugs in the past 2 years
Presence of uncontrolled active infection
Subjects who received autologous hematopoietic stem cell transplantation (ASCT) within 8 weeks of Screening Visit or who plan to undergo ASCT during the study.
Subjects who received allogeneic stem cell therapy.
Any condition that in the opinion of the Investigator, would interfere with evaluation of the IMP.
Received Bendamustine treatment 1 year prior to Screening Visit.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description OriCAR-017 OriCAR-017 Single OriCAR-017 infusion
- Primary Outcome Measures
Name Time Method Maximum tolerated dose (MTD) of OriCAR-017 US-P1 Up to 28 days 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.
Dose-limiting toxicity (DLT) Up to 28 days 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.
- Secondary Outcome Measures
Name Time Method Assessment of MRD negative Rate Up to 2 years Proportion of subjects with MRD negative status by flow cytometry
Assessment of Overall Survival (OS) of treatment in patients with RR/MM Up to 2 years OS as assessed by Local Investigators according to the IMWG Criteria
Assessment of Overall Response Rate (ORR) Up to 2 years Percentage of subjects with PR, + VGPR+ CR + strict complete response (sCR) as assessed by Local Investigator according to the IMWG criteria
Assessment of Clinical Benefit Rate (CBR) Up to 2 years Percentage of subjects with ORR + Minimal Response by Local Investigator according to IMWG Criteria
Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM Up to 2 years Assess concentration of CAR-T cells in peripheral blood
Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM Up to 2 years Assess PD markers related to CAR-T therapy in peripheral blood.
Assessment of Duration of Response (DOR) of treatment in patients with RR/MM Up to 2 years DOR as assessed by Local Investigators according to the IMWG Criteria
Progress-Free Survival (PFS) of treatment in patients with RR/MM Up to 2 years PFS as assessed by Local Investigators according to the IMWG Criteria
Assessment of Disease Control Rate (DCR) Up to 2 years Percentage of subjects with CBR (Clinical Benefit Rate) + Stable Disease as assessed by Local Investigator according to IMWG Criteria
Trial Locations
- Locations (1)
Northside Hospital
🇺🇸Atlanta, Georgia, United States