Dual-target CAR-T therapy (CAR19-BCMA) for relapsed or refractory multiple myeloma

Exploratory Clinical Study on the Safety and Efficacy of CAR19-BCMA Dual-target CAR-T in the Treatment of Relapsed / Refractory Multiple Myeloma

This trial will test whether a dual-target CAR-T cell therapy that targets CD19 and BCMA is safe and tolerable for adults with relapsed or refractory multiple myeloma.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: CAR-T
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07249073 on ClinicalTrials.gov

What this trial studies

This is an open-label, single-arm Phase I study using a 3+3 dose-escalation design to explore safety and define the maximum tolerated dose of CAR19-BCMA dual-target CAR-T cell infusion in relapsed or refractory multiple myeloma. The study will record in vivo pharmacokinetics of the infused CAR-T cells and collect preliminary efficacy data. Eligible patients must have BCMA and/or CD19 expression on myeloma cells and prior exposure or resistance to standard agents such as proteasome inhibitors, immunomodulatory drugs, or CD38 monoclonal antibodies. Safety, tolerability, and early anti-myeloma activity will guide dose selection for future studies.

Who should consider this trial

Good fit: Adults aged 18–70 with relapsed or refractory multiple myeloma who have BCMA and/or CD19 expression on myeloma cells, an ECOG performance status of 0–2, prior exposure to key myeloma drug classes, and the ability to consent and attend required visits are ideal candidates.

Not a fit: Patients who lack BCMA and CD19 expression on tumor cells, have poor performance status or severe comorbidities, or cannot travel to the treatment center are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the therapy could provide a new option that produces deeper or more durable remissions for patients whose myeloma has relapsed or become resistant to current treatments.

How similar studies have performed: BCMA-targeted CAR-T therapies have produced deep remissions in relapsed multiple myeloma, and early-phase dual-target approaches aiming to reduce antigen escape have shown promising but still preliminary signals.

Eligibility criteria

Inclusion Criteria:

Subjects must satisfy all the following criteria to be enrolled in the study:

1\. With Subjects' consent and signed informed consent, Subjects are willing and able to follow the planned visit, study treatment, laboratory examination and other test procedures; 2. Patients with relapsed / refractory multiple myeloma according to clinical diagnosis:

1. The expression of BCMA and / or CD19 in myeloma cells was positive confimed by flow cytometry or immunohistochemistry;
2. Patients with relapsed / refractory multiple myeloma who have received at least 1 line treatment (including proteasome inhibitors (PI), immunomodulatory drugs (IMID), CD38 mAb) or are resistant to proteasome inhibitors and / or immunomodulatory agents and / or CD38 mAb in the past.

3\. Age 18-70 years old, both male and female; 4. Subjects with physical fitness status of 0-2 in the Eastern Cooperative Oncology Group (ECOG) score; 5. The estimated survival time from the date of signing informed consent is more than 3 months; 6. Hgb ≥ 60g/L (transfusible); 7. Liver and kidney function and cardiopulmonary function meet the following requirements:

1. Creatinine ≤ 2 × ULN;
2. Left ventricular ejection fraction ≥ 50%;
3. Blood oxygen saturation \>90%;
4. Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; 8. Subjects with pregnancy plans must agree to take contraception before enrollment in the study and after six months of study duration; The investigator should be informed immediately if the subject is pregnant or suspected of pregnancy.

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   Exclusion Criteria:

   If any of the following criteria is met, you cannot be enrolled:

   1\. There were severe cardiac insufficiency and left ventricular ejection fraction \<50%; 2. Have a history of severe lung function impairment disease; 3. Combined with other advanced malignant tumors; 4. It was complicated with serious infection and could not be effectively controlled; 5. Complicated with severe autoimmune disease or innate immune deficiency; 6. Active hepatitis (hepatitis B virus deoxyribonucleic acid \[hbv-dna\] or hepatitis C virus ribonucleic acid \[hcv-rna\] test results are higher than the lower limit of detection); 7. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. One month after immunosuppressant withdrawal, patients with acute graft-versus-host response (GVHD) after allogeneic hematopoietic stem cell transplantation still exist; 10. There are other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study; 11. Female patients (patients with fertility) are in pregnancy or lactation. Note: severe infection: refers to the infection with uncontrolled sepsis or infection focus, which can be enrolled after infection control.

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Where this trial is running

Tianjin, Tianjin Municipality

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

Study contacts

• Principal investigator: Yan Xu, MD — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Yan Xu, MD

Conditions Multiple Myeloma