NCT04406610

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in treating with GD2 positive glioma patients.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Status
withdrawn

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 1, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 10, 2019

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

September 10, 2019

Last Update Submit

July 14, 2020

Conditions

Glioma of BrainCAR-T Cell Immunotherapy

Keywords

CAR-T cell immunotherapyGD2glioma

Outcome Measures

Primary Outcomes (1)

  • Classification of adverse reactions

    To observe the common 1-4 levels of side effects

    3 months

Secondary Outcomes (1)

  • Progression free survival （PFS）of patients

    1 year

Study Arms (2)

GD2 CAR-T

EXPERIMENTAL

Treated by GD2 CAR-T therapy intravenously

Biological: GD2 CAR-T immunotherapy

Control

NO INTERVENTION

With no medical intervention

Interventions

GD2 CAR-T immunotherapyBIOLOGICAL

Antigen-specific T cell therapy

Also known as: CAR-T for glioma
GD2 CAR-T

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
  • Body tumor 1-6, the maximum tumor length \< 2 cm
  • KPS ≥ 70, lifespan \> 6 months
  • Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

You may not qualify if:

  • Patients with cardiac pacemaker
  • Patients with brain metastasis
  • Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2019

First Posted

May 28, 2020

Study Start

September 1, 2015

Primary Completion

August 15, 2016

Study Completion

October 15, 2016

Last Updated

July 16, 2020

Record last verified: 2020-07