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A Study to Evaluate the Safety, PK/PD of (OriCAR-017) in Subjects With RR/MM - RIGEL Study


Active: Yes
Cancer Type: Multiple Myeloma NCT ID: NCT06271252
Trial Phases: Phase I Protocol IDs: OriCAR-017 US-P1 (primary)
NCI-2024-05382
Eligibility: 18 - 75 Years, Male and Female Study Type: Treatment
Study Sponsor: OriCell Therapeutics Co., Ltd.
NCI Full Details: http://clinicaltrials.gov/show/NCT06271252

Summary

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

Objectives

This is a Phase I/II, 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 relapsed/refractory multiple myeloma". The study
will consist of a Phase I dose escalation stage involving three doses as a single IV
infusion) with up to 18 evaluable subjects and a dose expansion stage with 10-15
evaluable subjects, followed by a Phase II stage with up to 48 evaluable subjects.

Treatment Sites in Georgia

Northside Hospital Cancer Institute - Bone Marrow Transplant (BMT)
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-851-8523


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