NCT04691349

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Sep 2020

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 27, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2021

Completed
Last Updated

January 11, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

December 28, 2020

Last Update Submit

January 8, 2021

Conditions

CAR-TChild, OnlyMalignant Tumor

Outcome Measures

Primary Outcomes (1)

  • ORR3

    3-month objective response rate

    Three months after CAR T cell infusion

Study Arms (1)

Chimeric antigen receptor T cell

EXPERIMENTAL

Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). 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. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells

Drug: CAR-T

Interventions

CAR-TDRUG

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.

Chimeric antigen receptor T cell

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chilren's Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

ShaoYan Hu

CONTACT

137-7187-0462hushaoyan@suda.edu.cn

HuiMin Meng

CONTACT

188-9680-2149huimin.meng@persongen.com.cn

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2020

First Posted

December 31, 2020

Study Start

September 27, 2020

Primary Completion

January 26, 2021

Study Completion

September 26, 2021

Last Updated

January 11, 2021

Record last verified: 2021-01

Locations

CN(1)