relapse/refractary B cell Acute Lymphoblastic Leukemia
Conditions
Interventions
single arm:Targeted CD19 Car-T cell therapy
Sponsors
Shanghai Children's Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.The guardian can effectively communicate with the researcher and sign the informed consent in writing; 2. Age: more than or equal to 3 years old and less than or equal to 18 years old, regardless of gender; 3. B-ALL confirmed by cytology and histology with reference to WHO classification of acute leukemia (2016 Revision) and diagnosis and treatment for childhood acute lymphoblastic leukemia (2018 Edition); 4. If CD19 is confirmed by flow cytometry, the test results should be provided within 3 months before enrolled; 5. Meet the definition of relapse or refractory in screening 1) More than two times of no remission after induction chemotherapy, and there was no suitable target drug or ineffective target treatment; 2) No remission of induction after BM relapses; 3) In the first non late stage (CCR = 45%. (the group can be enrolled if it meets the standard after correction); 10. Pulmonary function: dyspnea = 92% in indoor air environment; 11. The expected survival time is more than 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients with previous allergic history of human albumin and DMSO; 2. Had other malignant tumors within 3 years, except for carcinoma in situ (such as skin and cervix); 3. Active hepatitis B virus (HBV-DNA positive), hepatitis C virus antibody (HCV-RNA positive) or human immunodeficiency virus (HIV) infection; 4. Uncontrolled active infection: Systemic Fungus, bacteria, virus or other infection, etc; 5. In the past two years, the end organ has been damaged due to autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus). The systemic application of immunosuppressive or drugs for other systemic disease is required; 6. History of active or previous CNSL, or other clinically significant central nervous system diseases, such as epilepsy, paraplegia, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome. Note: Patients with central nervous system diseases under effective control can be selected; 7. Uncontrolled mental illness; 8. Combined with other life-threatening severe organ failure; 9. Participated in other clinical studies within 4 weeks; 10. Previously received car-t cells or other gene modified T cells; 11. Received live vaccination within 4 weeks; 12. Use of prohibited drugs: a. Corticosteroids: corticosteroids (defined as > 20mg / day prednisone or its equivalent) of therapeutic dosage used within 7 days before leukocyte collection or 72 hours before administration of gb5005. But physiological replacement, topical and inhaled steroids are allowed; b. Chemotherapy: rescue chemotherapy including tyrosine kinase inhibitor (TKI) within 1 week before leukocyte collection; c. Donor lymphocyte infusion (DLI) within 4 weeks before leukocyte collection; d. Graft versus host disease (GVHD): received systemic anti GVHD treatment within 3 months before the infusion of gb5005 cells; e. Alemtuzumab was used within 6 months before leukocyte collection, or flurubine or cladribine was used within 3 months; f. Use of checkpoint inhibitors or stimulants before enrollment (except for more than 3 biological half lives) 13. Patients with previous lung injury or hemorrhagic cystitis related to cyclophosphamide treatment are known; 14. The subjects judged by the researchers are difficult to complete all the visits or operations required by the study plan (including the follow-up period), or the compliance of participating in the study is insufficient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRD;Overall response rate (ORR);overall survive;CART-19 CELLS; | — |
Countries
China
Contacts
Public ContactJiang Hui
Shanghai Children's Hospital
Outcome results
None listed