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Study Evaluating the Efficacy and Safety With CAR-T for Relapsed or Refractory Neuroblastoma in Children

NCT02919046 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2017-03-14

No results posted yet for this study

Summary

This single-arm, multicenter clinical study will treat the patient who have relapsed or refractory neuroblastoma with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified to express the GD2 protein on the cell surface. The study will determine if these modified T cells help the body's immune system eliminate tumour cells .The trial will also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body and the impact on this treatment for survival.

Conditions

  • Relapsed or Refractory Neuroblastoma

Interventions

BIOLOGICAL

GD2-targeted CAR-T cells

This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-GD2-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.

Sponsors & Collaborators

  • Nanjing Children's Hospital

    collaborator OTHER

  • Children's Hospital of Fudan University

    collaborator OTHER

  • Sinobioway Cell Therapy Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yongjun Fang, Ph.D · Nanjing Children's Hospital

  • Kuiran Dong, Ph.D · Children's Hospital of Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919046 on ClinicalTrials.gov