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

Starting soon · Early Phase 1

Conditions studied: Multiple Myeloma (MM)

In brief

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.

Key facts

Study ID

NCT07539233

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

24

Starts

2026-04-15

Expected to finish

2029-08-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 before screening or pegylated G-CSF within 2 weeks before screening);
• Platelet count ≥ 50,000/μL;
• Lymphocyte count ≥ 500/μL;
• 7. Normal renal function: Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥45 mL/min;
• 8. Liver function must meet the following criteria:
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0× the upper limit of normal (ULN);
• Total bilirubin (TBIL) and alkaline phosphatase (AKP or ALP) ≤2.0× ULN (except for congenital hyperbilirubinemia, e.g., Gilbert's syndrome, direct bilirubin ≤1.5× ULN);
• Albumin ≥3 g/dL;
• 9. Cardiac function must meet the following criteria:
• Left ventricular ejection fraction ≥50% (by echocardiography or MUGA scan);
• No clinically significant pericardial effusion;
• No clinically significant electrocardiogram abnormalities;
• 10. Pulmonary function must meet the following criteria:
• Blood oxygen saturation ≥90% without oxygen supplementation;
• 11. Women of childbearing potential must have a negative pregnancy test at screening and before drug infusion and must not be breastfeeding.

You may not qualify if…

• 1.During screening, participants who have received other anticancer treatments (based mainly on investigator judgment):
• 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;
• Received immunomodulatory therapy within 1 week.
• Received radiotherapy within 4 weeks (if the radiotherapy covered ≤5% of bone marrow reserve, the subject is eligible regardless of the radiotherapy end date);
• 2. Received allogeneic hematopoietic stem cell transplantation within 6 months or autologous hematopoietic stem cell transplantation within 3 months before infusion;
• 3. Had malignancies other than MM before screening, except for: malignancies treated with curative intent, with no known active disease ≥2 years prior to enrollment; or adequately treated non-melanoma skin cancer with no evidence of disease currently;
• 4. Received any treatment using vesicular stomatitis virus G (VSVG) pseudotyped virus;
• 5. Had severe, uncontrolled infection symptoms (bacterial, viral, fungal, etc.) during the screening period;
• 6. Within 6 months before infusion, tested positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA levels above the normal range; tested positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA levels above the normal range; tested positive for human immunodeficiency virus (HIV) antibody; or tested positive for syphilis;
• 7. Had symptomatic heart failure or other serious cardiac diseases such as severe arrhythmias:
• New York Heart Association (NYHA) class III or IV congestive heart failure;
• Experienced myocardial infarction or underwent coronary artery bypass graft (CABG) or coronary stent implantation within 6 months prior to signing the ICF;
• Had clinically significant ventricular arrhythmias, or a history of unexplained syncope (excluding cases caused by vasovagal response or dehydration);
• Had a history of severe non-ischemic cardiomyopathy;
• 8. Other clinically significant diseases, including:
• Primary immunodeficiency;
• Stroke or seizure within 6 months prior to screening;
• Clear clinical evidence of dementia or altered mental status;
• Parkinson's disease or Parkinsonian movement disorders or history thereof;
• 9. Undergoing surgery within 2 weeks of administration or planned surgery within 2 weeks after administration, except for surgeries under local anesthesia;
• 10. Administration of live attenuated vaccines within 1 month before dosing;
• 11. Known severe allergic reaction to QI-019B or any of its formulation components;

Where it is running

• Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin Municipality, China

Full record on ClinicalTrials.gov

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