Actively Recruiting
A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study
Led by OriCell Therapeutics Co., Ltd. · Updated on 2024-08-02
81
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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...
- Able to provide signed informed consent
- Aged between 18 and 75 years at screening
- Expected to live longer than 12 weeks
- Diagnosed with multiple myeloma according to 2016 IMWG criteria
- Meet one of the following: serum M protein >10 g/L for IgG type, serum M protein >5 g/L for IgA, IgD, IgE, or IgM types, urine M protein >200 mg/24 hours, serum free light chain >100 mg/L with abnormal K/\u03bb ratio, or extramedullary lesions >1 cm in short axis diameter
- For Phase I dose escalation: at least 3 prior therapy lines, previous BCMA-Ag+ therapy exposure, refractory to last therapy
- For Phase I dose expansion and Phase II: prior exposure to BCMA-directed therapies including bispecific antibodies, antibody-drug conjugates, or CAR-T
- Adequate blood, kidney, liver, lung, and heart function
- Willingness to use effective contraception until 2 years after treatment
You will not qualify if you...
- Pregnant or breastfeeding
- Positive for HIV or active Hepatitis B or C infection
- Known active or past central nervous system involvement
- History of autoimmune diseases causing organ damage or requiring systemic immunosuppressive treatment in the last 2 years
- Active uncontrolled infection
- Received autologous stem cell transplant within 8 weeks before screening or planning one during the study
- Received allogeneic stem cell therapy
- Any condition that may interfere with study evaluation as judged by the investigator
- Received Bendamustine treatment within 1 year prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Northside Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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