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CAR T-cell Therapy

OriCAR-017 for Lymphoproliferative Disorders

Phase 1
Waitlist Available
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

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicity (DLT)
Maximum tolerated dose (MTD) of OriCAR-017 US-P1
Secondary outcome measures
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 more

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this clinical research study?

"Individuals eligible for this research study must exhibit lymphoproliferative disorders and fall within the age bracket of 18 to 75. The trial aims to enroll approximately 81 candidates."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"As per the details on clinicaltrials.gov, this particular study is not presently seeking new participants. Its initial posting was on April 15, 2024, with the latest update done a day prior to that deadline. Despite this trial being closed for recruitment, it's worth noting that there are currently 4062 other trials actively accepting patients for enrollment."

Answered by AI

What is the primary aim of conducting this clinical investigation?

"The objective of this investigation, to be evaluated within a period extending up to 28 days, is focused on identifying dose-limiting toxicity (DLT). Additional endpoints consist of Progress-Free Survival (PFS) in subjects with RR/MM as per the IMWG Criteria by Local Investigators, Evaluation of MRD negative Rate through flow cytometry for patients showing MRD negativity status, and Assessment of Disease Control Rate (DCR) defined as the ratio of individuals exhibiting CBR (Clinical Benefit Rate) + Stable Disease based on evaluations by Local Investigator following IMWG Criteria."

Answered by AI

Is the clinical trial allowing participation from individuals older than 75 years?

"Patient eligibility for this research demands individuals between the ages of 18 and 75. Notably, there are a total of 444 investigations focused on minors under 18 years old and 3750 studies targeting participants over 65 years old."

Answered by AI

What are the potential risks associated with OriCAR-017 in individuals?

"Our assessment at Power rates the safety of OriCAR-017 as a 1 on our scale. This is due to its Phase 1 trial status, indicating only preliminary data supporting both safety and efficacy."

Answered by AI
~54 spots leftby Dec 2025