Actively Recruiting
OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM
Led by OriCell Therapeutics Co., Ltd. · Updated on 2024-05-31
83
Participants Needed
5
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open label, dose exploratory clinical study to evaluate the safety, efficacy, and pharmacokinetics of OriCAR-017 in R/RMM
CONDITIONS
Official Title
OriCAR-017 Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of R/RMM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsed or refractory multiple myeloma according to IMWG criteria
- Expected survival longer than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 at consent
- GPRC5D expression in bone marrow plasma cells greater than 20% by flow cytometry or immunohistochemistry
- Multiple myeloma with measurable lesions meeting at least one: serum M protein >5 g/L; urine M protein >200 mg/24 hours; serum free light chain >100 mg/L with abnormal K/\u03bb ratio; or primitive immature/monoclonal plasma cells >5% by bone marrow cytology or flow cytometry
- Received at least 3 prior therapy lines including immunomodulatory drugs, proteasome inhibitors, or anti-CD38 antibodies but with treatment failure, relapse within 12 months, refractory or intolerant to last treatment
You will not qualify if you...
- Smoldering (asymptomatic) myeloma
- Multiple myeloma with only extramedullary lesions
- Plasma cell leukemia
- Concurrent amyloidosis
- Central nervous system metastasis, leptomeningeal disease, or metastatic central compression
- Positive hepatitis B surface antigen or core antibody with HBV DNA >100 copies/L
- Positive hepatitis C antibody and RNA
- Positive HIV antibody
- Positive syphilis antibody at screening
- Positive cytomegalovirus DNA test
- Hypersensitivity or intolerance to any study drug or excipient including conditioning chemotherapy
- Prior treatment targeting GPRC5D including antibodies, ADC, or CAR-T
- Autologous stem cell transplant within 8 weeks before screening or planned during study
- Uncontrolled active infection within 4 weeks before consent requiring parenteral antibiotics, antivirals, or antifungals
- Major surgery within 28 days before screening except biopsy or central venous catheter insertion
- Previous allogeneic stem cell therapy
- Any condition affecting protocol compliance or suitability as judged by investigators
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The First Affiliated Hospital College of Medicine Zhejiang University
Hangzhou, Zhejiang, China, 310003
Actively Recruiting
2
Beijing GoBroad Hospital
Beijing, China
Not Yet Recruiting
3
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China
Not Yet Recruiting
4
Tongji Hospital of Tongji University
Shanghai, China
Not Yet Recruiting
5
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Actively Recruiting
Research Team
H
HE Huang, MD
CONTACT
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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