Relapsed and refractory acute B lymphocytic leukemia
Conditions
Interventions
experimental group:CD19 CAR-T and CD22 CAR-T sequential therapy
Sponsors
The First Affiliated Hospital of Zhejiang University
Eligibility
Sex/Gender
All
Age
8 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Subjects with relapsed and refractory acute B lymphocytic leukemia who meet the following conditions: (1) The positive expression of CD19 and CD22 in tumor cells is associated with relapsed and refractory cases. (2) The tumor burden is high and cannot be directly transplanted. CAR-T cell therapy can reduce the burden and achieve remission. (3) If DLI relapses after transplantation, the donor cells in the recipient can be used, or the donor cells can be directly collected to prepare CAR-T to prevent relapse and induce remission. (4) Repeated MRD-positive refractory cases. (5) Extramedullary lesions that are difficult to cure with radiotherapy and chemotherapy. 2. Expected survival > 12 weeks. 3. Aged 8-75 years. 4. Transplant subjects, regardless of their previous treatment, are eligible after relapse. 5. Women of childbearing age who have a negative urine pregnancy test before the start of administration and agree to take effective contraceptive measures during the trial period until the last follow-up visit. 6. Those who voluntarily participated in this trial and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. Those with a history of epilepsy or other central nervous system diseases; 2. Patients with prolonged QT period or severe heart disease in the past; 3. Pregnant or lactating patients (the safety of this therapy for unborn children is not known); 4. Those with active infection who have not been cured; 5. Active hepatitis B or hepatitis C virus infection; 6. Those who use systemic steroids within 2 weeks before participating in treatment (except those who are using inhaled steroids recently or currently); 7. Those who have used any gene therapy products before; 8. Those with insufficient amplification ability (2.5mg/dl or ALT/AST>3 times normal or bilirubin>2.0mg/dl; 10. Suffering from other uncontrolled diseases, which the investigator considers unsuitable to join; 11. HIV-infected persons; 12. Any situation that the investigator believes may increase the risk of the subject or interfere with the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limited toxicity;adverse event incidence;titer of auto-antibody; | — |
Countries
China
Contacts
Public ContactHuang He
The First Affiliated Hospital of Zhejiang University
Outcome results
None listed