NCT05437315

GD2/PSMA Bi-specific CAR-T Cell Therapy

GD2/PSMA Bi-specific CAR-T Cells For the Treatment of GD2 and PSMA Positive Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Shenzhen Geno-Immune Medical Institute · Academic / Other
• Sex: All
• Age: 1 Year – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2/PSMA bi-specific CAR-T cell therapy in patients with GD2 and PSMA positive tumor. Another goal of the study is to learn more about the function of the anti-GD2/PSMA bi-specific CAR-T cells and their persistency in patients.

Detailed description

Patients with refractory and/or recurrent solid tumors have poor prognosis despite complex multimodal therapy; therefore, novel curative approaches are needed. The investigators are attempting to use T cells obtained directly from the patient, which can be genetically modified to express a 4th generation anti-GD2/PSMA bi-specific chimeric antigen receptor (bi-4SCAR-GD2/PSMA). The chimeric antigen receptor (CAR) molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen, GD2 or PSMA, which is expressed at high levels on tumor cells but not at significant levels on normal tissues. Disialoganglioside (GD2) is a well-studied tumor associated antigen which is expressed uniformly in nervous system-related tumors but at low levels in normal tissues. Over the past few years, CAR-T therapy against GD2 in tumor has achieved encouraging but modest outcomes. Only a fraction of patients achieved measurable responses. In solid tumors, GD2 CAR-T therapy alone may not as effective as CAR-T cell therapy in hematological malignancies. Prostate-specific membrane antigen (PSMA) is expressed in normal prostate and upregulated in prostate tumor. Therefore, PSMA is a promising target for immunotherapy of prostate cancer. However, PSMA is not restricted to prostate cancer and it is known that PSMA is enriched in the tumor stromal environment. Based on immunostaining, it is confirmed that PSMA is expressed in a variety of solid tumors, including brain tumor, neuroblastoma and some lymphomas. To overcome tumor escape of single target antigen and enhance in vivo CAR-T efficacy, a novel bi-specific GD2/PSMA CAR-T therapy regimen is developed to include booster and consolidation CAR-T applications to target highly-refractory cancer. The aim is to evaluate safety and long term efficacy of the bi-CAR-T therapy strategy in GD2 and/or PSMA positive cancer patients.

Conditions

• Solid Tumor

Interventions

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

Timeline

• Start date: 2022-06-30
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2022-06-29
• Last updated: 2022-06-29

Locations

1 site across 1 country: China