CAR-T, Child, Only, Malignant Tumor
Conditions
Brief summary
This study is a clinical study of CAR-T treatment of patients with relapsed/refractory malignant tumors in children. The purpose is to evaluate the safety and effectiveness of chimeric antigen receptor T cells in the treatment of relapsed/refractory malignant tumors in children.
Interventions
DRUGCAR-T
The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region.
Sponsors
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Age 3-18 * Expected survival time ≥ 12weeks * ECOG 0-2 * At least second-line or above chemotherapy failed * Liver and kidney function, heart and lung function meet the following requirements: Creatinine is within the normal range; Left ventricular ejection fraction ≥ 45%; Baseline blood oxygen saturation\>91%; Total bilirubin≤1.5×ULN; ALT and AST≤2.5×ULN * Understand the trial and have signed the informed consent
Exclusion criteria
* Those who have graft-versus-host disease (GVHD) or need to use immunosuppressive agents * Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer test is not within the normal reference range; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) Antibody positive; CMV DNA test positive; Syphilis test positive * Severe heart disease * Systemic diseases judged by the investigator to be unstable: including but not limited to severe liver, kidney or metabolic diseases that require medication * Within 7 days before screening, there are active infections or uncontrollable infections that require systemic treatment (except for mild urogenital infections and upper respiratory tract infections) * Those who have received CAR-T therapy or other genetically modified cell therapy before screening * According to the researcher's judgment, it does not meet the situation of cell preparation * Situations that other researchers think are not suitable for inclusion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ORR3 | Three months after CAR T cell infusion | 3-month objective response rate |
Countries
China
Contacts
Primary ContactShaoYan Hu
Backup ContactHuiMin Meng
Outcome results
None listed