Status:
UNKNOWN
CAR-T for r/r Malignant Tumors in Children
Lead Sponsor:
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Conditions:
CAR-T
Child, Only
Eligibility:
All Genders
3-18 years
Phase:
EARLY_PHASE1
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 recepto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 26 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04691349
Start Date
September 27 2020
End Date
September 26 2021
Last Update
January 11 2021
Active Locations (1)
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1
Chilren's Hospital of Soochow University
Suzhou, Jiangsu, China, 215000