NCT03252171

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

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

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withdrawn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

October 15, 2015

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2016

Completed
1 year until next milestone

First Posted

Study publicly available on registry

August 17, 2017

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

October 18, 2015

Last Update Submit

July 14, 2020

Conditions

GD2 Positive GliomaCAR-T Cell Immunotherapy

Keywords

CAR-T cell immunotherapyGD2glioma

Outcome Measures

Primary Outcomes (1)

  • The effectiveness of CAR-T cell immunotherapy

    It will be evaluated by the Response Evaluation Criteria in Solid Tumors（RECIST）

    3 months

Secondary Outcomes (1)

  • Progress free survival（PFS）

    1 year

Other Outcomes (1)

  • Overall survival（OS）

    3 years

Study Arms (2)

Experimental: CAR-T cell immunotherapy

EXPERIMENTAL

Enrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen by infusion.

Biological: CAR-T cell immunotherapy

No Intervention

NO INTERVENTION

Interventions

CAR-T cell immunotherapyBIOLOGICAL

This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen.

Experimental: CAR-T cell immunotherapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The primary GD2 positive patients, the best are glioma patients.
  • The recurrent GD2 positive patients, the best are glioma patients.
  • Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:
  • Absolute neutrophil count greater than 1500/mm3.
  • Platelet count greater than 100,000/mm3.
  • Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).
  • Total bilirubin \< 1.5 times upper limits of normal.
  • Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).
  • Seronegative for HIV antibody.
  • Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.
  • Patients must be willing to practice birth control during and for four months following treatment.
  • NOTE: women of child-bearing age must have evidence of negative pregnancy test.
  • Patients must be willing to sign an informed consent.

You may not qualify if:

  • The patients with multiple kinds of cancers are excluded.
  • Patients with uncontrolled hypertension (\> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.
  • Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), \< 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) \< 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.
  • Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.
  • Pregnant and/or lactating women will be excluded.
  • Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.
  • Patients with any type of primary immunodeficiencies will be excluded from the study.
  • Patients requiring corticosteroids (other than inhaled) will be excluded.
  • Patients with history of T cell tumors will be excluded.
  • Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central laboratory in Fuda cancer hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Glioma

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Adoptive TransferImmunization, PassiveImmunizationImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Lizhi Niu, PhD

    Fuda Cancer Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2015

First Posted

August 17, 2017

Study Start

October 15, 2015

Primary Completion

August 15, 2016

Study Completion

August 15, 2016

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations

CN(1)