Refractory/relapsed CD19-positive B-cell leukemia
Conditions
Interventions
Low dose level:infuse 5.0×10^5 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. Clinically diagnosed as relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia; (1) At least 2-4 cycles of chemotherapy done in the past but did not reach complete remission; (2) Relapse after chemotherapy or targeted therapy; (3) Unsuitable or inappropriate for hematopoietic stem cell transplantation; (4) Relapse after hematopoietic stem cell transplantation; (5) Patients with simple extramedullary B-ALL infiltration; (6) Patients with CD19-positive B-lymphocytic leukemia who have been treated with drugs without CART, CD19-negative but gene MRD-positive; 2. Aged 18 to 70 years old; 3. US Eastern Cooperative Oncology Group (ECOG) Scale of Performance 2 points; 4. The patient has self-awareness and can sign the informed consent, legally authorized personnel by the patient sign the informed consent, or guardians of minor patients sign the informed consent and are willing to participate in the study voluntarily.
Exclusion criteria
Exclusion criteria: 1. Pregnant or nursing woman; 2. Uncontrolled infection; 3. Active hepatitis B or hepatitis C; 4. Patients who used steroids within a week before cell infusion; 5. Drug-uncontrollable central nervous system lesions; 6. Patients with GVHD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PBMC CAR-T+Tcell, CD19+Bcell; | — |
Countries
China
Contacts
Public ContactJunfang Yang
Hebei Yanda Lu Daopei Hospital
Outcome results
None listed