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.

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