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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • QI-019A Injection

Treatment groups

24 Participants
are divided into 1 treatment group