A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019B in Patients With Relapsed/Refractory Multiple Myeloma.
NCT07539233 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-04-20
Summary
This is a single-arm, open-label, single-center clinical trial to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of QI-019B in patients with relapsed/refractory multiple myeloma.
Conditions
- Multiple Myeloma (MM)
Interventions
- DRUG
-
QI-019B Injection
QI-019B 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.
Sponsors & Collaborators
-
Institute of Hematology & Blood Diseases Hospital, China
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-15
- Primary Completion
- 2028-08-01
- Completion
- 2029-08-01
Countries
- China
Study Locations
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