Refractory/Relapsed Hematology and Oncology Disease in Children
Conditions
Interventions
Pediatric Refractory and Relapsed Leukemia and Lymphoma:Infusion of CAR-T cells targeting CD19, CD22, CD20, CD79b, CD38, CD33, CD123, CD133, CLL1, and other antigens
Pediatric Refractory and Relapsed Neuroblastoma:Infusion of CAR-T cells targeting GRP78, GPC2, ROR1, GD2, B7H3, HER2, CD171, IL13Ra2, EGFRvIII and other antigens
Pediatric Refractory and Relapsed hepatoblastoma:Infusion of CAR-T cells targeting GRP78, GPC2, ROR1, GD2, B7H3, HER2, CD171, IL13Ra2, EGFRvIII and other antigens
Pediatric Refractory and Relapsed rhabdomyosarcoma:Infusion of CAR-T cells targeting GRP78, GPC2, ROR1, GD2, B7H3, HER2, CD171, IL13Ra2, EGFRvIII and other antigens
Pediatric Refractory and Relapsed glioma:Infusion of CAR-T cells targeting GRP78, GPC2, ROR1, GD2, B7H3, HER2, CD171, IL13Ra2, EGFRvIII and other antigens
Sponsors
Shanghai Children's Medical Center, Affiliated to Shanghai Jiaotong University, School of Medicine
Eligibility
Sex/Gender
All
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: Patients with relapsed or refractory childhood leukaemia, lymphoma, neuroblastoma, hepatoblastoma, rhabdomyosarcoma, and glioma who are younger than 18 years of age at disease onset have been tested for the presence of CD19, CD22, CD20, CD79b, CD38, CD33, CD123, CD133, CLL1, GRP78, GPC2, ROR1, GD2, B7H3, HER2, CD171, IL13Ra2, EGFRVIII, etc., which have been verified by domestic and international experiments, and satisfy the following conditions: 1. patients with initial diagnosis are determined to meet the criteria for the definition of refractory in their respective diseases after chemotherapy; 2. the disease has progressed during chemotherapy in patients with initial diagnosis, and the prognosis of chemotherapy is expected to be poor; 3. patients with one or more relapses with clear evidence of residual tumour; 4. patients with disease recurrence after autologous or allogeneic haematopoietic stem cell transplantation; 5. patients with tumours that cannot be cured by current means of surgery, radiotherapy and chemotherapy.
Exclusion criteria
Exclusion criteria: Any of the following conditions will not be eligible for enrolment in this study: 1) Age >18 years at disease onset; 2) Expected survival is 2.5mg/dl; ALT/AST >5 times normal; total bilirubin >2mg/dl; 7) Controlled active infection; 8) Active hepatitis B, hepatitis C, or HIV infection; 9) Early loss of follow-up after treatment (<3 months); 10) Failure to sign an informed consent form or without the consent of the Ethics Committee; 11) Presence of other systemic diseases that interfere with the study; 12) Other indicators that can be excluded in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Minimal Residual Disease (MRD);Event-free Survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| B Cell Reconstruction;CAR-T cell persistence;Imaging examination; | — |
Countries
China
Contacts
Public ContactBenshang Li
Shanghai Children's Medical Center affiliated to school of medicine, Shanghai Jiaotong University
Outcome results
None listed