GA NCORP

NCORP Trials

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

Status
Active
Cancer Type
Multiple Myeloma
Trial Phase
Phase I
Eligibility
18 - 75 Years, Male and Female
Study Type
Treatment
NCD ID
NCT06271252
Protocol IDs
OriCAR-017 US-P1 (primary)
NCI-2024-05382
Study Sponsor
OriCell Therapeutics Co., Ltd.

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


 
For a complete listing of all trial sites in Georgia, please visit GeorgiaCancerInfo.org