NCT05707325

Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell in Patients With Advanced Malignancies

A Multicenter, Single-arm, Open-label, Dose-escalation and Dose-expansion Clinical Study Evaluating the Safety, Tolerability and Preliminary Efficacy of Engineered Red Blood Cell in Patients With Advanced Malignancies

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Westlake Therapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an investigator-initiated trial aimed at evaluating the safety and preliminary efficacy of a novel red blood cell-based therapy, where engineered red blood cells are conjugated with checkpoint inhibitors.

Detailed description

The present study has 2 parts，including dose escalation and dose expansion。The dose escalation part is carried out according to the "3+3" increasing principle. At least four dose groups are predefined based on the number of engineered red blood cells, specifically 1e11, 2e11, 3e11, 3.5e11,etc. Dose expansion part will be decided according to dose escalation part.

Conditions

• Cancer
• Solid Tumor
• Hematologic Malignancy

Interventions

Type	Name	Description
DRUG	engineered red blood cell	engineered red blood cell

Timeline

• Start date: 2023-01-16
• Primary completion: 2025-12-31
• Completion: 2026-07-31
• First posted: 2023-01-31
• Last updated: 2024-07-24

Locations

1 site across 1 country: China