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.
1. Age ≥ 18 years, any gender;
2. Diagnosed with multiple myeloma (MM) according to IMWG diagnostic criteria;
3. Have received at least 2 lines of anti-MM treatment, with at least one full treatment cycle per line, and experienced disease progression during the most recent anti-myeloma treatment or within 12 months after it, confirmed by available clinical evidence; or deemed by the investigator to be refractory to both immunomodulatory agents and proteasome inhibitors, with disease progression during the most recent anti-myeloma treatment or within 2 months after it (according to IMWG diagnostic criteria);
Serum M protein level ≥ 0.5 g/dL;
Received targeted therapy, epigenetic therapy, other investigational drugs, or treatment using invasive research medical devices within 5 half-lives;
Received immune/non-immune-directed systemic therapy within 1 week;
Received cytotoxic therapy within 2 weeks;
Received proteasome inhibitors within 2 weeks;
Single group
QI-019A Injection
DrugQI-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.
The number and severity of dose-limiting toxicity (DLT)events
Dose-limiting toxicity (DLT) refers to a grade ≥3 toxic reaction that occurs within the DLT observation period and is considered by the investigator or collaborators to have a reasonable association with QI-019A treatment (toxicity grading is based on CTCAE 5.0 standards, while grading for cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) follows the 2019 ASTCT consensus criteria).
The total number, incidence, and severity of Adverse Events(AEs)
The total number, incidence, and severity of Adverse Events(AEs). All other AEs would be assessed according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Overall response rate (ORR）
Clinical efficacy can be evaluated according to the 2016 International Myeloma Working Group consensus criteria.
Complete response (CR) rate
sCR/CR can be evaluated according to the 2016 International Myeloma Working Group consensus criteria.
Duration of response (DOR)
DOR is defined as the interval between the first sCR, CR, VGPR, or PR after infusion and the disease progression or death.
Progression-free survival (PFS)
PFS is defined as the interval between a subject's receipt of QI-019A infusion and the first assessment of disease progression or death.
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