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

NCT07539233 | Not Yet Recruiting Early Phase 1

• 1 other identifier: IIT2026025
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma (MM)

Keywords

BCMA; CD19; CAR-T; in vivo

Outcome Measures

Primary Outcomes (2)

• 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-019B 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)

  Within 28 Days After QI-019B infusion

• 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)

  Within 28 Days After QI-019B infusion

Secondary Outcomes (8)

• Overall response rate (ORR）

  Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of QI-019B

• Complete response (CR) rate

  Day 14, Day 28, Month 2 , Month 3, Month 6, Month 9, Month 12, Month 18, Month24 after the treatment of QI-019B.

• Duration of response (DOR)

  Through study completion, an average of 2 year

• Progression-free survival (PFS)

  up to 2 years after treatment of QI-019B.

• Overall survival (OS)

  up to 2 years after treatment of QI-019B

Study Arms (1)

QI-019B Injection

EXPERIMENTAL

QI-019B 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.

Drug: QI-019B Injection

Interventions

QI-019B Injection DRUG

QI-019B 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.

QI-019B Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥ 18 years, any gender;
• \. Diagnosed with multiple myeloma (MM) according to IMWG diagnostic criteria;
• \. 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);
• \. 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;
• \. ECOG performance status 0-2, with an expected survival of ≥ 3 months;
• \. 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;
• \. Normal renal function: Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥45 mL/min;
• \. Liver function must meet the following criteria:

You may not qualify if:

• 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);
• \. Received allogeneic hematopoietic stem cell transplantation within 6 months or autologous hematopoietic stem cell transplantation within 3 months before infusion;
• \. 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;
• \. Received any treatment using vesicular stomatitis virus G (VSVG) pseudotyped virus;
• \. Had severe, uncontrolled infection symptoms (bacterial, viral, fungal, etc.) during the screening period;
• \. 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;
• \. 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;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300000, China

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2029
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

CN (1)