NCT06644118

A Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

A Pilot Clinical Study of OL-101 Injection in Patients with Relapsed or Refractory Multiple Myeloma (RRMM)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial aims to characterize the safety of OL-101 and establish the recommended dose for future research and to evaluate the efficacy of OL-101 (Dose expansion).

Detailed description

This study will evaluate the safety and efficacy of OL-101, a chimeric antigen receptor T cell (CAR-T) therapy directed against B-Cell Maturation Antigen (BCMA) and G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D). This study is a single-arm, open-label, early exploratory clinical trial, conducted in two phases: dose escalation and dose expansion in adults with multiple myeloma. The trial begins with the dose-escalation phase that focus on safety and tolerability, with interval assessments for potential dose escalation or de-escalation. Recommended dose will be selected at the completion of the dose escalation stage in the dose expansion stage. The study aims to assess safety, pharmacokinetic/pharmacodynamic profiles, and efficacy.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	OL-101 infusion	OL-101 infusion will be administered to patients via IV infusion at the assigned dose.

Timeline

• Start date: 2024-10-23
• Primary completion: 2027-10-01
• Completion: 2028-10-01
• First posted: 2024-10-16
• Last updated: 2024-11-08

Locations

3 sites across 1 country: China