for relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma
Conditions
Interventions
Treatment group :CAR-T Cell Therapy
Sponsors
Navy General Hospita
Eligibility
Sex/Gender
All
Age
14 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 14-65 years old, male/female; 2. Subjects or their legal guardians participate in this experiment voluntarily and informed consent form must be signed; 3. In accordance with National Comprehensive Cancer Network (NCCN) ALL Guidelines for Patients (2016, v.1) and CD19+B-ALL patients diagnosed by histology; 4. In accordance with r/r CD19+ B-ALL diagnosis, including any of the following situations: (1) Getting through 2 treatments of standard chemotherapy with CR not yet obtained; (2) Reach CR for the first inducement, but CR lasts for ?12 months; (3) r/r CD19+ B-ALL for no positive effect after first or repeated remedial treatment; (4) ?2 times of recurrence; 5. Remedial chemotherapy is not used within 4 weeks before cell therapy; 6. Immunosuppressive drug is not used within 4 weeks before cell therapy, including but not limited to systemic hormone therapy; 7. Antibody drug treatment is not received within 2 weeks before cell therapy; 8. Normal cardiac motion shown by echocardiography, left ventricular ejection fraction (LVEF) =50%, with no pericardial effusion and severe symptoms of cardiac arrhythmia; 9. No pulmonary active infection is found, with normal pulmonary function and indoor air SaO2 ?92% 10. No contraindications for leukapheresis; 11. Expected survival >3 months; 12. Grade 0 or 1 of ECOG performance status.
Exclusion criteria
Exclusion criteria: 1) Pregnant and breastfeeding women; 2) Uncontrolled active infection; 3) Uncontrolled infectious disease is diagnosed, such as HIV, syphilis, hepatitis A, hepatitis B, hepatitis C and E; 4) Patients who have used a large amount of glucocorticoid or other immunosuppressive drugs within 4 weeks; 5) Stage II-IV Acute/chronic general graft versus host disease; 6) Gene therapy has been undergone in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical efficacy rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactShengdian Wang
Navy General Hospital
Outcome results
None listed