refractory and relapsed acute B-lymphocytic leukemia
Conditions
Interventions
Low dose level:infuse 0.5×10^6 CAR+ T Cells/kg
Sponsors
Hebei Yanda Lu Daopei Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All of the following criteria must be met for admission: (1) aged 2 to 70 years; the expected survival period should be > 3 months; (2) Relapsed or refractory CD19+ B-ALL ; Patients with B-ALL after Hematopoietic stem cell transplantation had to be transplanted 6 months postoperatively; (3) ECOG score = 1 x 10^9 / l); (6) Women of child-bearing age must be examined for negative urine pregnancy tests within seven days and must use appropriate contraception during the period of the test and within three months after the test; (7) The patient or guardian agrees to participate in the clinical study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: Compliance with any exclusion criteria shall not be included in the group: (1) Pregnant or lactating women (women of childbearing age need to be examined for pregnancy); (2) Serious infectious diseases or viral diseases (HIV positive, syphilis, etc.); (3) Active hepatitis B or C; (4) Patients who had used a lot of glucocorticoids within one week; (5) Patients with severe heart, liver, renal insufficiency, diabetes and other diseases; (6) Have participated in other clinical studies or been treated with other cell products in the past 3 months; (7) MR diagnosis of CSF and brain: leukemia cells invading central nervous system were not controlled; (8) B-ALL patients with active GVHD after hematopoietic stem cell transplantation. (9) Severe Allergic Constitution; (10) There are other serious diseases (such as autoimmune diseases, immune deficiency, organ transplantation) that are in conflict with this program; (11) There is other history of malignant tumor; (12) There are serious mental disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse events;Response rate to treatment;Disease-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate; | — |
Countries
China
Contacts
Public ContactJunfang Yang
Hebei Yanda Lu Daopei Hospital
Outcome results
None listed