CAR-T for r/r Malignant Tumors in Children

Child, Only Clinical Trial

Official title:

Chimeric Antigen Receptor T Cells Therapy for r/r Malignant Tumors in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04691349
• Other study ID #: PG-CART-01
• Status: Recruiting
• Phase: Early Phase 1
• Start date: September 27, 2020
• Est. completion date: September 26, 2021

Study information

• Verified date: January 2021
• Source: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
• Contact: ShaoYan Hu
• Phone: 137-7187-0462
• Email: hushaoyan[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 26, 2021
• Est. primary completion date: January 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• CAR-T
• Child, Only
• Malignant Tumor
• Neoplasms

Intervention

Drug:
• CAR-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.

Locations

Country	Name	City	State
China	Chilren's Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
PersonGen BioTherapeutics (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR3	3-month objective response rate	Three months after CAR T cell infusion