Trials Sponsors Conditions Drugs Pricing

Conditions

Solid Tumor

Keywords

CARchimeric antigen receptoradoptive T cell transfer

Outcome Measures

Primary Outcomes (1)

Number of patients with adverse events.
Determine the toxicity profile the 4SCAR-GD2-modified T cells with Common Toxicity Criteria for Adverse Effects version 4.0
3 year

Secondary Outcomes (5)

Anti-tumor effects
3 year
The expansion and persistence of anti-GD2 CAR T cells
3 year
Immune responses after anti-GD2 infusions
1 year
Immune responses after anti-GD2 infusions
1 year
Survival time of the patients
3 year

Study Arms (1)

effectiveness of 4SCAR-GD2 T cells

EXPERIMENTAL

The 4SCAR-GD2-modified T cells can recognize and kill tumor cells through the recognize of GD2 .This study will evaluate the side effects and effective doses of 4SCAR-GD2 T cells in treating refractory and recurrent solid tumors

Genetic: 4SCAR-GD2

Interventions

4SCAR-GD2Genetic

GD2-specific 4th Generation CART

Also known as: GD2-specific 4th Generation CART

effectiveness of 4SCAR-GD2 T cells

Eligibility Criteria

Age1 Year - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Patients with tumors have received standard first-line therapy and been judged to be non-resectable，metastatic,progressive or recurrent.
The GD2 antigen status of the tumor will be determined for eligibility.Positive expression is defined by GD2 antibody staining results based on immunohistochemistry or flow cytometry analyses.

Sponsors & Collaborators

Shenzhen Geno-Immune Medical Institute
Otherlead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

Lung-Ji Chang, PhDCONTACT+86-13671121909 c@mkgimi.com

Study Officials

Lung-Ji Chang
Shenzhen Geno-Immune Medical Institute
PRINCIPAL INVESTIGATOR

Central Study Contacts

Lung-Ji Chang, PhD.

CONTACT

+86 0755-86573763 c@mkgimi.com

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director

Study Record Dates

First Submitted

December 3, 2016

First Posted

December 14, 2016

Study Start

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

Primary Completion

June 2028

Study on GD2 Positive Solid Tumors by 4SCAR-GD2

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

effectiveness of 4SCAR-GD2 T cells

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (1)

effectiveness of 4SCAR-GD2 T cells

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations