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Donor Derived CD19 CAR-T Cells in the Treatment of R/R B-cell Acute Lymphoblastic Leukemia

RecruitingEARLY Phase 1Ages 18 Years - anyAllZhejiang University
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In plain words

What the trial is, and whether it could suit you

A Clinical Study on the Safety and Effectiveness of donor derived CD19 CAR-T Cells in the treatment of R/R B-cell acute lymphoblastic leukemia

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 1\. Age ≥18 years old, gender unlimited; * 2\. Abnormal B cell immunotyping was CD19 positive; * 3\. Patients diagnosed with B-cell acute lymphoblastic leukemia by histological or immunotyping; * 4\. Meets the diagnosis of relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and includes any of the following conditions: 1. No CR was obtained after standard chemotherapy; 2. CR was induced for the first time, but the duration of CR was less than 12 months; 3. R/R B-ALL that does not work after the first or more remedial treatments; 4. Two or more relapses; * 5\. The researchers believed that the patient had been adequately treated, such as auto-HSCT, auto-CART could not be prepared or preparation failed. Autologous CAR-T preparation failure was defined as including too few autologous lymphocytes (\<1×109) or insufficient expansion during preparation or failure to meet the release criteria; * 6\. Total bilirubin ≤51 ( μmol/L), alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal, creatinine ≤176.8 (μmol/L); * 7\. Absolute neutrophil count: ≥ 0.5×109/L; Platelet: ≥ 30×109/L; Hemoglobin ≧60g/L; * 8\. Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%; * 9\. The estimated survival is more than 3 months; * 10\. ECOG score 0-2; * 11\. Women and men who are fertile must consent to the use of appropriate contraception before entering the study, during study participation, and for 6 months after transfusion (the safety of this therapy for the unborn child is not known, with unknown risks); * 12\. Subjects who are willing to participate in the study are able to understand and have the ability to sign informed consent. Exclusion Criteria: * 1\. Known allergies to research preconditioning measures, etc; * 2\. People with a history of epilepsy or other central nervous system disorders; * 3\. People with a history of prolonged QT or severe heart disease; * 4\. Less than 100 days after receiving allogeneic hematopoietic stem cell transplantation; * 5\. Hiv-infected person; * 6\. Persons with active hepatitis B or C virus; Those who are not cured have active infections; * 7\. Insufficient amplification ability (\< 5x) in response to CD3 / CD28 costimulatory signals; * 8\. Combined use of systemic steroids (e.g., prednisone ≥20mg) within 3 days prior to screening, except for ongoing or intermittent use of topical, inhaled or intranasal steroids within 2 weeks or at present; Or have systemic diseases that require long-term use of immunological agents; * 9\. Patients who received anti-cancer chemotherapy or other drugs within 2 weeks prior to screening; * 10\. Any situation that the investigator believes may increase the risk of the subjects or interfere with the study results.
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What it tests

  • CD19 B-cell Acute Lymphoblastic Leukemia Targeted CAR T-cells injection
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Where

1 site
The first affiliated hospital of medical college of zhejiang university
Hangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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