NCT05877651

MASCT-I in Patients With Metastatic or Recurrent Solid Tumors Who Failed Standard Therapy.

A Single-center, Phase I Clinical Study to Evaluate the Safety and Tolerability of Multi-Antigen Stimulated Cell Therapy-I Injection (MASCT-I) in Patients With Metastatic or Recurrent Solid Tumors Who Failed Standard Therapy.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: HRYZ Biotech Co. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of MASCT-I in patients with metastatic or recurrent solid tumors who failed standard therapy.

Detailed description

The study is divided into two stages. The first stage is divided into two groups, both of which adopted 3+3 design. The first group is given MASCT-I by administration method 1, and the second group is given by method 2. One of the administration method will be used in the second stage according to DLT and adverse events found in the first stage.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	MASCT-I injection	The final products of MASCT-I technology are dendritic cells (DC) and effector T cells

Timeline

• Start date: 2020-04-21
• Primary completion: 2021-10-15
• Completion: 2021-10-15
• First posted: 2023-05-26
• Last updated: 2023-05-30

Locations

1 site across 1 country: China