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.
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;