refractory/recurrent malignant tumors
Conditions
Interventions
experimental group:CART
Sponsors
Children's Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
No minimum to 18 Years
Inclusion criteria
Inclusion criteria: (1) Aged 0.001 after Standard first-line treatment; b) disease recurrence or progression after standard treatment; c) at least 1 tumor focus can be evaluated; (5) liver and kidney function, heart and lung function meet the following requirements: a) creatinine = 45% ; c) SpO2 >90% ; d) TBIL <= 2 ULN; (6) understand the study and have signed an informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with graft-versus-host disease (GVHD) or requiring immunosuppressive therapy; (2) Patients with positive HBsAg or HBcAb and peripheral blood HBV DNA titers were not within the normal reference range; HCV antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; CMV DNA Positive; syphilis positive; (3) Severe heart disease: including but not limited to unstable angina, myocardial infarction (6 months prior to screening), heart failure (NYHA classification >= III), Severe Arrhythmia; (4) Systemic diseases that the researchers determined were unstable: including, but not limited to, severe liver, kidney or metabolic diseases requiring drug treatment; (5) Within 7 days prior to screening, the presence of an active or uncontrolled infection requiring systemic treatment (except for mild genitourinary and upper respiratory tract infection infections); (6) Subjects who were receiving systemic steroid therapy at the time of screening and who, in the judgment of the investigators, required long-term systemic steroid therapy during the treatment period (except for inhalation or topical use); (7) Subjects who, in the judgment of the investigators, does not correspond to the case of cell preparation; (8) Other researchers do not consider suitable for inclusion in the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-week, 4-week, 8-week, 3-month ORR;2-week, 4-week, 8-week, 3-month ORR;OS;DOR;DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cmax;Tmax; | — |
Countries
China
Contacts
Public ContactHu Shaoyan
Children's Hospital of Soochow University
Outcome results
None listed