Refractory/relapsed B-cell hematological malignancies
Conditions
Interventions
flexible dose group:Infusion of CAR+ T Cells/kg
Sponsors
The First People's Hospital of Yunnan Province
Eligibility
Sex/Gender
All
Age
1 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. With the consent of the person (or authorized client/or legal guardian) and signed informed consent, willing and able to comply with the planned visits, research treatment, laboratory tests and other test procedures; 2. Patients with refractory/recurrent hematological malignancies determined by clinical diagnosis, including leukemia, lymphoma, etc.; Definition of refractory or relapsed leukemia: Diagnosed by histopathology; received at least 2-4 cycles of chemotherapy but did not achieve complete remission; relapsed after chemotherapy or targeted therapy remission; unsuitable or unconditional for hematopoietic stem cell transplantation patients; patients with relapse after hematopoietic stem cell transplantation; patients with pure extramedullary B-ALL infiltrates; primary CD19-positive B lymphocytic leukemia, patients with CD19-negative and no CART treatment after drug treatment, but gene MRD-positive patients. Definition of refractory or relapsed lymphoma: Histopathologically diagnosed; patients with relapsed or refractory B-cell lymphoma who have received a standard chemotherapy regimen and a salvage regimen with rituximab or other CD20 antibody drugs and at least two chemotherapy regimens suitable for their disease, one of which should include anthracyclines; after these regimens, patients maintain SD (SD duration = 1 year old, = 12 weeks; 5. The expression of the relevant target antigen is positive; 6. Eastern Cooperative Oncology Group Activity Status Score (EOCG) 0-2; 7. Able to understand and voluntarily sign the informed consent; if the subject is a child, the guardian shall sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breastfeeding women; 2. Has an uncontrolled infection; 3. Active hepatitis B or C; 4. Patients who have used steroid hormones within 1 week before reinfusion; 5. Patients who have used Rituxan two weeks before reinfusion; 6. Central nervous system lesions that cannot be controlled by drugs; 7. Active GVHD patients; 8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; 9. Other diseases that may conflict with this clinical trial include cardiovascular, neurological, psychiatric diseases, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| DOR;Adverse effects incidence;PBMC CAR-T+T cell; | — |
Countries
China
Contacts
Public ContactXuezhong Gu
Outcome results
None listed