Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05437341
Status:
RECRUITING
Last Update Posted:
2022-06-29
First Post:
2022-06-21
Brief Title:
PSMACD70 Bi-specific CAR-T Cell Therapy
Sponsor:
Shenzhen Geno-Immune Medical Institute
Organization:
Shenzhen Geno-Immune Medical Institute
Study Overview
Official Title:
PSMACD70 Bi-specific CAR-T Cells for Cancer Treatment
Status:
RECRUITING
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the feasibility safety and efficacy of anti-PSMACD70 bi-specific CAR-T cell therapy in patients with CD70 and PSMA positive malignancies Another goal of the study is to learn more about the function of the PSMACD70 bi-specific CAR-T cells and their persistency in patients
Detailed Description:
Patients with refractory andor recurrent cancer have poor prognosis despite complex multimodal therapy therefore novel curative approaches are needed The investigators attempt to use T cells genetically modified to express a 4th generation lentiviral anti-PSMACD70 bi-specific chimeric antigen receptor bi-4SCAR-PSMACD70 The chimeric antigen receptor CAR molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen CD70 or PSMA which is expressed at high levels on tumor cells but not at significant levels on normal tissues
CD70 is a promising therapeutic target due to its restricted expression in normal tissues and overexpression in malignant tissues Expression of CD70 was observed on multiple tumor types including kidney breast esophageal liver colon cancer glioma lymphoma as well as melanoma In addition it has been reported that anti-CD70 CAR T-cell therapy eliminated primary CD70-positive cells and had strong anti-tumor effects in preclinical animal models The CD70 targeted CAR-T cells with binding moiety of CD70 specific scFv exhibit a higher affinity and antitumor effect against CD70 tumor cells
Prostate-specific membrane antigen PSMA is expressed in normal prostate and upregulated in prostate tumor 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 Therefore PSMA is a promising target for immunotherapy of many types of cancer
A potential strategy to prevent relapse due to antigen escape is to infuse T-cells capable of recognizing multiple antigens To overcome tumor escape of single target antigen and enhance in vivo CAR-T efficacy a novel bi-specific PSMACD70 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 CD70 andor PSMA positive cancer patients
CD70 is a promising therapeutic target due to its restricted expression in normal tissues and overexpression in malignant tissues Expression of CD70 was observed on multiple tumor types including kidney breast esophageal liver colon cancer glioma lymphoma as well as melanoma In addition it has been reported that anti-CD70 CAR T-cell therapy eliminated primary CD70-positive cells and had strong anti-tumor effects in preclinical animal models The CD70 targeted CAR-T cells with binding moiety of CD70 specific scFv exhibit a higher affinity and antitumor effect against CD70 tumor cells
Prostate-specific membrane antigen PSMA is expressed in normal prostate and upregulated in prostate tumor 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 Therefore PSMA is a promising target for immunotherapy of many types of cancer
A potential strategy to prevent relapse due to antigen escape is to infuse T-cells capable of recognizing multiple antigens To overcome tumor escape of single target antigen and enhance in vivo CAR-T efficacy a novel bi-specific PSMACD70 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 CD70 andor PSMA positive cancer patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None