NCT06271252

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

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.

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: OriCell Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Neoplasms, Plasma Cell
• Neoplasms by Histologic Type
• Neoplasms
• Hemostatic Disorders
• Vascular Diseases
• Cardiovascular Diseases
• Paraproteinemias
• Blood Protein Disorders
• Hematologic Diseases
• Hemorrhagic Disorders
• Lymphoproliferative Disorders
• Immunoproliferative Disorders
• Immune System Diseases
• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	OriCAR-017	Anti-GPRC5D CAR-T cell product

Timeline

• Start date: 2024-04-03
• Primary completion: 2026-12-12
• Completion: 2028-04-12
• First posted: 2024-02-21
• Last updated: 2024-08-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study