Refractory/relapsed acute B-lymphoblastic leukemia (B-ALL)
Conditions
Interventions
Fixed dose group:infuse 1.0x10^6 CAR+ T Cells/kg
Sponsors
Hebei Yanda Lu Daopei Hospital
Eligibility
Sex/Gender
All
Age
1 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of refractory/recurrent CD19, CD22 double positive B-ALL: (1) Have received at least 2-4 cycles of combination chemotherapy but have not achieved complete response; (2) Relapse after remission with chemotherapy or targeted therapy or CD19 CAR T immunotherapy; (3) Patients who are not suitable or unconditional for hematopoietic stem cell transplantation; (4) Patients with recurrence after hematopoietic stem cell transplantation; 2. Aged >=1 year, < 70 years; 3. Activity Status Score (EOCG)<=2; 4. Able to understand and voluntarily sign the informed consent; If the subject is a child, the guardian will sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating patients; 2. Have an uncontrolled infection; 3. Active hepatitis B or C; 4. Patients who had used steroid hormones within 1 week before reinfusion; 5. Central nervous system leukemia that cannot be controlled by drugs; 6. Patients with active GVHD; 7. Other diseases that may be in conflict with this clinical trial, including cardiovascular, neurological and psychiatric diseases, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| CD19+B cell;The amount of CD22+B cells;Adverse effects incidence; | — |
Secondary
| Measure | Time frame |
|---|---|
| Peripheral blood CAR T+ cells;Disease remission rate;Duration of remission; | — |
Countries
China
Contacts
Public ContactZhang Xian
Outcome results
None listed