A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019B in Patients With Rela… (NCT07539233) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
A Clinical Study to Evaluate the Safety and Preliminary Efficacy of QI-019B in Patients With Relapsed/Refractory Multiple Myeloma.
China24 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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);
* 4\. Disease must be measurable at screening, meeting one or more of the following criteria:
* Serum M protein level ≥ 0.5 g/dL;
* Or urine M protein level ≥ 200 mg/24h;
* Or involved serum free light chain ≥ 10 mg/dL with abnormal serum free light chain κ/λ ratio;
* 5\. ECOG performance status 0-2, with an expected survival of ≥ 3 months;
* 6\. Bone marrow function test results (from screening or within 2 months prior) meet the following requirements:
* Hemoglobin ≥ 6 g/dL (no red blood cell transfusion within 1 week before screening), recombinant human erythropoietin allowed; for patients meeting the ≥ 6 g/dL hemoglobin requirement at screening, red blood cell transfusions are allowed to maintain hemoglobin ≥ 6 g/dL;
* Absolute neutrophil count (ANC) ≥ 600/μL (no use of granulocyte colony-stimulating factor (G-CSF) within 1 week…
What they're measuring
1
The number and severity of dose-limiting toxicity (DLT)events
Timeframe: Within 28 Days After QI-019B infusion
2
The total number, incidence, and severity of Adverse Events(AEs)
Timeframe: Within 28 Days After QI-019B infusion
Trial details
NCT IDNCT07539233
SponsorInstitute of Hematology & Blood Diseases Hospital, China