Trials Sponsors Conditions Drugs Pricing

Conditions

Solid Tumor

Keywords

CAR-TSolid tumorGD2PSMA

Outcome Measures

Primary Outcomes (1)

Number of patients with adverse events.
Determine the toxicity profile the bi-4SCAR GD2/PSMA cells with Common Toxicity Criteria for Adverse Effects version 4.0
6 months

Secondary Outcomes (6)

Anti-tumor effects
1 year
Anti-tumor effects
1 year
The persistence of bi-4SCAR GD2/PSMA T cells
1 year
The expansion bi-4SCAR GD2/PSMA T cells
1 year
Survival time of the patients
3 years
+1 more secondary outcomes

Study Arms (1)

bi-4SCAR-GD2/PSMA T Cell Therapy for GD2 and PSMA positive tumor

EXPERIMENTAL

Biological: bi-4SCAR GD2/PSMA T cells

Interventions

bi-4SCAR GD2/PSMA T cellsBiological

Infusion of bi-4SCAR GD2/PSMA T cells at 10\^6 cells/kg body weight via IV

bi-4SCAR-GD2/PSMA T Cell Therapy for GD2 and PSMA positive tumor

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age1 Year - 75 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 have been judged to be non-resectable, metastatic, progressive or recurrent.
The expression status of GD2 or PSMA antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and PMSA 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 0755-86573763 c@szgimi.org

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

+86 0755-86573763 c@szgimi.org

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 21, 2022

First Posted

June 29, 2022

Study Start

December 31, 2026

Estimated

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

Primary Completion

December 31, 2029

Estimated

GD2/PSMA Bi-specific CAR-T Cell Therapy

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 (6)

Study Arms (1)

bi-4SCAR-GD2/PSMA T Cell Therapy for GD2 and PSMA positive tumor

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

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 (6)

Study Arms (1)

bi-4SCAR-GD2/PSMA T Cell Therapy for GD2 and PSMA positive tumor

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations