Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05436496
Status:
RECRUITING
Last Update Posted:
2022-06-29
First Post:
2022-06-22
Brief Title:
CD1970 Bi-specific CAR-T Cell Therapy
Sponsor:
Shenzhen Geno-Immune Medical Institute
Organization:
Shenzhen Geno-Immune Medical Institute
Study Overview
Official Title:
CD1970 Bi-specific CAR-T Cells Targeting B Cell Malignancies
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 CD1970 bi-specific CAR-T cell therapy in patients with CD19 andor CD70 positive B cell malignancies Another goal of the study is to learn more about the safety and function of the anti-CD1970 bi-specific CAR-T cells and their persistency in patients
Detailed Description:
Patients with refractory andor recurrent B cell malignancies have poor prognosis despite complex multimodal therapy Despite impressive progress more than 50 of patients treated with CD19-targeting chimeric antigen receptor T cells CAR19 experience progressive disease Further more than 40 patients with progressive large B cell lymphoma LBCL experienced reduced or lost expression of CD19 on the tumor cells after CAR19 treatment low surface CD19 density before treatment was associated with progressive disease Therefore novel curative approaches are needed The investigation attempts to use genetically modified T cells to express a 4th generation lentiviral anti-CD1970 bi-specific CAR bi-4SCAR-CD1970 The CAR molecules enable the T cells to recognize and kill tumor cells through the recognition of a surface antigen CD19 or CD70 which is expressed at high levels on tumor cells but not at significant levels on normal tissues
CD70 is highly expressed in many cancers but limited in normal tissues it is a potential CAR-T therapeutic target Expression of CD70 was observed on multiple tumor types including solid tumor as well as B cell malignancies In addition it has been reported that anti-CD70 CAR T-cells can eliminate CD70-positive cells and exhibit 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-positive tumor cells 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 CD1970 CAR-T therapy regimen is developed to include booster and consolidation CAR-T applications to target highly-refractory B cell cancer The aim is to evaluate safety and long term efficacy of the bi-CAR-T therapy strategy in CD19 andor CD70 positive cancer patients
CD70 is highly expressed in many cancers but limited in normal tissues it is a potential CAR-T therapeutic target Expression of CD70 was observed on multiple tumor types including solid tumor as well as B cell malignancies In addition it has been reported that anti-CD70 CAR T-cells can eliminate CD70-positive cells and exhibit 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-positive tumor cells 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 CD1970 CAR-T therapy regimen is developed to include booster and consolidation CAR-T applications to target highly-refractory B cell cancer The aim is to evaluate safety and long term efficacy of the bi-CAR-T therapy strategy in CD19 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