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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: ec@ihcams.ac.cn
• Phone: 13920593907

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

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• Understanding CAR-T Toxicities After Cilta-Cel in Multiple Myeloma

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• PD-1Ab21-BCMA CAR-T consolidation for multiple myeloma with renal dysfunction

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• DC/MM fusion vaccine plus BCMA CAR-T for relapsed or refractory multiple myeloma

  This trial will test whether adding a personalized DC/MM fusion vaccine (with GM‑CSF) to standard BCMA CAR‑T therapy helps people with relapsed or refractory multiple myeloma.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.