NCT07429721

A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019A in Patients With Relapsed/Refractory Multiple Myeloma.

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of QI-019A in patients with relapsed/refractory multiple myeloma.

Detailed description

This investigator-initiated clinical study aims to evaluate QI-019A, the lentiviral vector that carries a BCMA/CD19-targeted CAR, in patients with relapsed or refractory multiple myeloma (MM). The study employs a dose-escalation design to assess safety, tolerability, and preliminary efficacy.

Conditions

• Multiple Myeloma (MM)

Interventions

Type	Name	Description
DRUG	QI-019A Injection	QI-019A Injection is an in vivo administered CAR-T gene therapy product that uses a lentiviral vector as the delivery system. Its mechanism of action involves transducing and integrating into the target T cell genome in the patient through the lentiviral vector, achieving stable expression of the CAR transgene, thereby generating CAR-T cells within the body.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-06-01
• Completion: 2029-06-01
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

1 site across 1 country: China