NCT05194709

Study of Anti-5T4 CAR-NK Cell Therapy in Advanced Solid Tumors

Clinical Trial of Anti-5T4 Oncofetal Trophoblast Glycoprotein (5T4) Conjugated Antibody Redirecting Natural Killer (CAR-NK) Cells in Advanced Solid Tumors

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Wuxi People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is an interventional, single arm, open-label, investigator-initiated trial (IIT) to evaluate the safety, tolerability, initial efficacy and pharmacokinetics (PK) of anti-5T4 CAR-NK cells in patients with advanced solid tumors.

Detailed description

The treatment cycle in this study is 21 days. The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle. Subjects will be treated continuously until the criteria for termination of treatment are met. In this study, the dose escalation design is adopted. The first administration dose in the first cycle is 3.0×10\^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10\^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10\^9 cells.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	Anti-CAR-NK Cells	The administration of CAR-NK cell will be performed on day 1 and day 3 of each cycle (21 days). The first administration dose in the first cycle is 3.0×10\^9 cells. If no adverse events were observed, the second administration dose in the first cycle would be 4.0×10\^9 cells, and each administration dose in the second cycle and thereafter would be 4.0×10\^9 cells.

Timeline

• Start date: 2021-12-30
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2022-01-18
• Last updated: 2022-02-02

Locations

1 site across 1 country: China