Actively Recruiting
A Phase III, 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 RelapsedRefractory Multiple Myeloma
Led by OriCell Therapeutics Co., Ltd. · Updated on 2024-08-02
81
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, pharmacokinetics, pharmacodynamics, and preliminary effectiveness of an anti-GPRC5D CAR-T cell product called OriCAR-017 in adults with relapsed or refractory multiple myeloma. This Phase III open-label study is the first clinical trial of OriCAR-017 in the United States by OriCell Therapeutics Co., Ltd., aiming to find suitable dosing and assess early treatment results in this patient group. The study includes a Phase I dose escalation stage with three different doses given as a single intravenous infusion to up to 18 participants. This is followed by a dose expansion stage with 10-15 participants and then a Phase II stage that may include up to 48 participants. Each participant receives one infusion of OriCAR-017 to evaluate its effects and safety. Participants will be closely monitored for up to two years after treatment. Researchers will assess the maximum tolerated dose and dose-limiting toxicities within 28 days after infusion. They will also study how the drug moves through and affects the body, measure response duration, progression-free survival, overall survival, and other response rates. Regular evaluations include laboratory tests, clinical assessments, and safety monitoring throughout the study period.
CONDITIONS
Brief Title
A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Capable of giving signed informed consent
- Aged 18 to 75 years inclusive at screening
- Expected survival period greater than 12 weeks
- Diagnosed with multiple myeloma according to IMWG criteria (2016 version)
- For IgG type MM, serum M protein greater than 10 g/L; for IgA, IgD, IgE, or IgM type MM, serum M protein greater than 5 g/L
- Urine M protein level greater than 200 mg/24 hour
- For light chain type MM, serum free light chain greater than 100 mg/L with abnormal K/λ ratio
- Presence of extramedullary lesions larger than 1 cm in diameter
- For Phase I dose-escalation: received at least 3 prior lines of therapy, prior BCMA-Ag+ therapies exposure, refractory to last therapy
- For Phase I dose-expansion and Phase II: prior exposure to BCMA therapies including bispecific antibodies, antibody-drug conjugates, or CAR-T
- Adequate hematologic, renal, hepatic, pulmonary, and cardiac function
- Willingness of subject and partner to use effective contraception until 2 years post infusion
You will not qualify if you...
- Pregnant or breastfeeding
- Seropositive for HIV or active Hepatitis B or C infection
- Known active or prior CNS involvement
- History of autoimmune diseases causing organ damage or requiring systemic immunosuppressive therapy in past 2 years
- Presence of uncontrolled active infection
- Received autologous hematopoietic stem cell transplantation within 8 weeks of screening or plans to undergo during study
- Received allogeneic stem cell therapy
- Any condition interfering with evaluation of the investigational medicinal product
- Received Bendamustine treatment within 1 year prior to screening
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