Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06271252
Other study ID # OriCAR-017 US-P1
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 3, 2024
Est. completion date April 12, 2028

Study information

Verified date May 2024
Source OriCell Therapeutics Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 information / eligibility

Status Recruiting
Enrollment 81
Est. completion date April 12, 2028
Est. primary completion date December 12, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 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/? 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. Exclusion Criteria: 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


Intervention

Drug:
OriCAR-017
Anti-GPRC5D CAR-T cell product

Locations

Country Name City State
United States Northside Hospital Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
OriCell Therapeutics Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum 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. Up to 28 days
Primary 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. Up to 28 days
Secondary Evaluate PK parameters of OriCAR-017 in subjects with relapsed/refractory MM Assess concentration of CAR-T cells in peripheral blood Up to 2 years
Secondary Evaluate PD parameters of OriCAR-017 in subjects with relapsed/refractory MM Assess PD markers related to CAR-T therapy in peripheral blood. Up to 2 years
Secondary Assessment of Duration of Response (DOR) of treatment in patients with RR/MM DOR as assessed by Local Investigators according to the IMWG Criteria Up to 2 years
Secondary Progress-Free Survival (PFS) of treatment in patients with RR/MM PFS as assessed by Local Investigators according to the IMWG Criteria Up to 2 years
Secondary Assessment of Overall Survival (OS) of treatment in patients with RR/MM OS as assessed by Local Investigators according to the IMWG Criteria Up to 2 years
Secondary Assessment of MRD negative Rate Proportion of subjects with MRD negative status by flow cytometry Up to 2 years
Secondary 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 Up to 2 years
Secondary 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 Up to 2 years
Secondary Assessment of Clinical Benefit Rate (CBR) Percentage of subjects with ORR + Minimal Response by Local Investigator according to IMWG Criteria Up to 2 years
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Recruiting NCT05654272 - Development of CIRC Technologies
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT04056208 - Pistachios Blood Sugar Control, Heart and Gut Health Phase 2
Recruiting NCT04417387 - The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
Not yet recruiting NCT06211361 - Cardiac Rehabilitation Program in Patients With Cardiovascular Disease N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04514445 - The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT03273972 - INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers N/A
Completed NCT03680638 - The Effect of Antioxidants on Skin Blood Flow During Local Heating Phase 1
Recruiting NCT04843891 - Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis. Phase 1
Completed NCT04083846 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed) Phase 1
Completed NCT04083872 - Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting) Phase 1
Completed NCT03693365 - Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
Completed NCT03466333 - Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia Phase 2
Completed NCT03619148 - The Incidence of Respiratory Symptoms Associated With the Use of HFNO N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Completed NCT05132998 - Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors N/A
Completed NCT05067114 - Solutions for Atrial Fibrillation Edvocacy (SAFE)