Cardiovascular Diseases Clinical Trial
Official title:
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.
Verified date | May 2024 |
Source | OriCell Therapeutics Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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. |
Country | Name | City | State |
---|---|---|---|
United States | Northside Hospital | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
OriCell Therapeutics Co., Ltd. |
United States,
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 |
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