B-cell hematologic malignancies
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 5-70 years; 2. Expected survival beyond 12 weeks; 3. Patients with CD19+ hematologic malignancies diagnosed by pathology and histology; 4. Patients could not achieve complete response after chemotherapy; 5. Patients with with relapsed disease after chemotherapy; 6. Creatinine 50; 10. Patients without severe liver, kidney, heart disease; 11. Patients with relapsed disease after hematopoietic stem cell transplantation; 12. Not eligible or appropriate for hematopoietic stem cell transplantation; 13. Voluntary participation in the clinical trials; 14. Venous blood could be obtained or no contraindications for white blood collection; 15. Sign the consent form.
Exclusion criteria
Exclusion criteria: 1. Patients in pregnancy or breast-feeding period; Planning pregnancy within 6 months; 2. HIV or active TB infected; 3. Active hepatitis B or hepatitis C infection; 4. Feasibility assessment during screening demonstrates <10% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation; 5. Patients with abnormal vital signs or could not cooperate with inspectors; 6. History of mental disorders; 7. Highly allergic constitution or severe allergies, especially allergic to IL-2; 8. Systemic infection or serious infections should be local anti-infection treatment; 9. With heart, lung, brain, kidney and other important organ dysfunction; 10. Presence of severe autoimmune disease; 11. Other situations we think improper for the research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete remission rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression Free Survival;Overall Survival;Safety; | — |
Countries
China
Contacts
The Affiliated Hospital of Xuzhou Medical University