Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05438368
Status:
RECRUITING
Last Update Posted:
2022-06-30
First Post:
2022-06-21
Brief Title:
GD2CD70 Bi-specific CAR-T Cell Therapy
Sponsor:
Shenzhen Geno-Immune Medical Institute
Organization:
Shenzhen Geno-Immune Medical Institute
Study Overview
Official Title:
GD2CD70 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 GD2CD70 bi-specific CAR-T cell therapy in patients with GD2 andor CD70 positive tumor Another goal of the study is to learn more about the function of the GD2CD70 bi-specific CAR-T cells and their persistency in patients
Detailed Description:
Patients with refractory andor recurrent cancer may 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-GD2CD70 bi-specific chimeric antigen receptor bi-4SCAR-GD2CD70 The chimeric antigen receptor CAR molecules enable the T cells to recognize and kill target cells through the recognition of a surface antigen GD2 or CD70 which is expressed at high levels on cancer 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 be as effective as CAR-T cell therapy in hematological malignancies
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 hepatoma as well as melanoma In addition it has been reported that anti-CD70 CAR T-cells eliminated 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 exhibited a higher affinity and antitumor effect against CD70 tumor cells A potential strategy to prevent relapse due to antigen escape is to infuse T-cells capable of recognizing multiple antigens
To overcome escape of single target antigen in tumor cells and to enhance in vivo CAR-T efficacy a novel bi-specific GD2CD70 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 andor CD70 positive cancer patients
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 be as effective as CAR-T cell therapy in hematological malignancies
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 hepatoma as well as melanoma In addition it has been reported that anti-CD70 CAR T-cells eliminated 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 exhibited a higher affinity and antitumor effect against CD70 tumor cells A potential strategy to prevent relapse due to antigen escape is to infuse T-cells capable of recognizing multiple antigens
To overcome escape of single target antigen in tumor cells and to enhance in vivo CAR-T efficacy a novel bi-specific GD2CD70 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 andor CD70 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