Overview
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
Description
In this study, 15 patients with relapsed refractory B-cell acute lymphoblastic leukemia were proposed to undergo CD19 CAR-T Cells therapy. Under the premise that its safety has been clarified in previous studies, further observation and evaluation of the effectiveness of CD19 CAR-T Cells therapy for relapsed refractory B-cell acute lymphoblastic leukemia; At the same time, on the basis of expanding the sample size, more safety data on CD19 CAR-T Cells treatment for relapsed refractory B-cell acute lymphoblastic leukemia were accumulated.
Eligibility
Inclusion Criteria:
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- Age ≥18 years old, gender unlimited;
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2. Abnormal B cell immunotyping was CD19 positive;
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3. Patients diagnosed with B-cell acute lymphoblastic leukemia by histological or
immunotyping;
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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;
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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;
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6. Total bilirubin ≤51 ( μmol/L), alanine aminotransferase (ALT)/aspartate
aminotransferase (AST) ≤ 3 times the upper limit of normal, creatinine ≤176.8
(μmol/L);
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7. Absolute neutrophil count: ≥ 0.5×109/L; Platelet: ≥ 30×109/L; Hemoglobin
≧60g/L;
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8. Echocardiography showed left ventricular ejection fraction (LVEF) ≥40%;
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9. The estimated survival is more than 3 months;
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10. ECOG score 0-2;
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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);
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12. Subjects who are willing to participate in the study are able to understand and
have the ability to sign informed consent.
Exclusion Criteria:
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- Known allergies to research preconditioning measures, etc;
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2. People with a history of epilepsy or other central nervous system disorders;
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3. People with a history of prolonged QT or severe heart disease;
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4. Less than 100 days after receiving allogeneic hematopoietic stem cell
transplantation;
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5. Hiv-infected person;
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6. Persons with active hepatitis B or C virus; Those who are not cured have active
infections;
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7. Insufficient amplification ability (< 5x) in response to CD3 / CD28
costimulatory signals;
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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;
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9. Patients who received anti-cancer chemotherapy or other drugs within 2 weeks
prior to screening;
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10. Any situation that the investigator believes may increase the risk of the
subjects or interfere with the study results.