NCT04427449

4SCAR-CD44v6 T Cell Therapy Targeting Cancer

Multi-center Phase I/II Clinical Trial of 4SCAR-CD44v6 T Cells for Treating Cancer

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Shenzhen Geno-Immune Medical Institute · Academic / Other
• Sex: All
• Age: 6 Months – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of 4SCAR-CD44v6 T-cell therapy targeting multiple cancers. The study also aims to learn more about the function of the CD44v6 CAR-T cells and their persistency in the patients.

Detailed description

CD44 variant domain 6 (CD44v6) which belongs to CD44 family has been implicated in tumorigenesis, tumor cell invasion and metastasis. The expression of CD44v6 was reported for the majority of squamous cell carcinomas, a proportion of adenocarcinomas of differing origin, a proportion of melanoma and lymphoma. This expression pattern has made CD44v6 an attractive target for the therapy of various types of CD44v6 positive cancers. The T cells from patients or transplantation donors will be genetically modified with lentiviral CAR vector to recognize specific molecules - CD44v6 expressed on the surface of the cancer cells. The engineered T cells will be applied to patients through intravenous delivery. The purpose of this clinical trial is to assess the feasibility, safety and efficacy of CD44v6 CAR-T cell therapy in multiple cancers including - but not limited to - stomach cancer, breast cancer, prostate cancer, multiple myeloma and lymphoma which are CD44v6 positive. Another goal of the study is to learn more about the function of the 4SCAR-CD44v6 T cells and their persistency in the patients.

Conditions

• Cancers Which Are CD44v6 Positive

Interventions

Type	Name	Description
BIOLOGICAL	CD44v6-specific CAR gene-engineered T cells	4SCAR-CD44v6 Infusion of 4SCAR-CD44v6 T cells at 10\^6 cells/kg body weight

Timeline

• Start date: 2020-06-01
• Primary completion: 2023-05-31
• Completion: 2023-12-31
• First posted: 2020-06-11
• Last updated: 2020-06-11

Locations

4 sites across 1 country: China