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CAR T-cell Therapy
OriCAR-017 for Multiple Myeloma
Phase 1
Recruiting
Research Sponsored by OriCell Therapeutics Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is the first study conducted by Oricell Therapeutics Inc. in the United States. It aims to assess the safety, how the body processes the drug, how the drug works in the
Who is the study for?
This trial is for adults aged 18-75 with relapsed/refractory multiple myeloma, who have tried at least three prior treatments and are refractory to the last one. They must meet specific criteria based on their type of myeloma protein levels and have a life expectancy over 12 weeks.
What is being tested?
The RIGEL Study is testing OriCAR-017, an anti-GPRC5D cell product by Oricell Therapeutics Inc., focusing on its safety, how it's processed in the body (PK/PD), and initial effectiveness in treating multiple myeloma patients.
What are the potential side effects?
While specific side effects for OriCAR-017 aren't listed here, similar therapies may cause immune reactions, infusion-related symptoms, fatigue, blood count changes, increased infection risk, and potential impact on organ function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose-limiting toxicity (DLT)
Maximum tolerated dose (MTD) of OriCAR-017 US-P1
Secondary study objectives
Assessment of Clinical Benefit Rate (CBR)
Assessment of Disease Control Rate (DCR)
Assessment of Duration of Response (DOR) of treatment in patients with RR/MM
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: OriCAR-017Experimental Treatment1 Intervention
Single OriCAR-017 infusion
Find a Location
Who is running the clinical trial?
OriCell Therapeutics Co., Ltd.Lead Sponsor
3 Previous Clinical Trials
203 Total Patients Enrolled