Relapsed or Refractory B-cell acute lymphoblastic leukemia
Conditions
Interventions
Case series:chimeric antigen receptor T cell immunotherapy
Sponsors
Beijing Shijitan Hospital,Capital Medical University
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1. Aged 24 months to 18 years old; 2. Relapsed or refractory B-cell acute lymphoblastic leukemia (CD19 positive, and/or CD22/CD20 positive,etc), defined as MRD in bone marrow =0.01%, or extramedullary relapse after HSCT, or patients did not achieve complete remission after > 2 or more chemotherapy regimens, or unable to receive allo-HSCT; 3. Estimated life expectancy = 3 months; 4. Body weight = 10kg; 5. Normal organ function, ECOG = 2; 6. More than 30 days since last chemotherapy, blood tests show Hb=70g/L,ANC=1.5×109/L,PLT=80×109/L; 7. Blood tests within 3 months: no evidence of HIV/Hepatitis B/Hepatitis C/Treponema pallidum infection; 8. Be adequate for leukapheresis; 9. Informed consent document should be signed by the parents or legal guardians of the childhood patients; 10. Comply with visiting schedules and other requirements , including follow-up survival assessments.
Exclusion criteria
Exclusion criteria: 1. Active central nervous system(CNS) disorders or leukemia; 2. With any concurrent malignancies, not clinically cured or relapsed within 5 years; 3. Uncontrolled active infection and tuberculosis; 4. Any form of serious complications, such as primary immunodeficiency disease or bone marrow failure syndrome; 5. Acute or chronic GVHD, Class II-IV (Glucksberg) or B-D (IBMTR) ; 6. Any of the following cardiac conditions within 6 months: stage III or IV congestive heart failure, congenital heart disease, cardiac angioplasty, myocardial infarction or other heart disease; 7. Chemotherapy within 30 days prior to enrollment; 8. Be pregnant ; 9. Steroid therapy within 7 days before leukapheresis, donor lymphocyte infusion (DLI) and drug treatment for GVHD within 4 weeks, Alemtuzumab therapy within 6 months, and Clofarabine or Cladribine therapy within 3 months before leukapheresis; 10. Severe immediate hypersensitivity reaction to any of the agents in this study; 11. Patients with psychiatric disorders ; 12. Monoclonal antibody therapy within 3 months before enrollment; 13. Vaccination of (attenuated) live virus vaccine within 1 month prior to enrollment; 14. Previous treatment with any gene therapy products; 15. Insufficient expansion of PBMC in response to CD3/CD28 stimulation; 16. Patients with autoimmune diseases; 17. Biphenotypic or biclone acute leukemia; 18. Unable to tolerate leukapheresis; 19. Other situations not suitable for the study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| overall response Summary;overall survival rate;Median Survival Time;event free survival; | — |
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events; | — |
Countries
China
Contacts
Public ContactXiaosong Zhong
Beijing Shijitan Hospital, Capital Medical University
Outcome results
None listed