NCT04074564

MASCT-I Combined With Apatinib and/or Camrelizumab in the Treatment of Bone and Soft Tissue Sarcoma

An Exploratory Study Evaluating the Safety and Efficacy of MASCT-I Combined With Apatinib Mesylate and/or Camrelizumab in the Treatment of Patients With Advanced Bone and Soft Tissue Sarcoma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: HRYZ Biotech Co. · Industry
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and preliminary efficacy of Multi-Antigen Stimulated Cell Therapy-I Injection (MASCT-I) in combination with Apatinib and/or Camrelizumab in patients with advanced bone and soft-tissue sarcoma.

Detailed description

This is a single-center, open-label, exploratory study to evaluate the safety, preliminary efficacy and immune response of MASCT-I with Apatinib and/or Camrelizumab in the treatment of patients with advanced bone and soft-tissue sarcoma. 60 patients with advanced bone and soft-tissue sarcoma will be recruited. This study include two parts. In part A, patients were randomized into two groups: one group received MASCT-I A+Camrelizumab+Apatinib, and the other group received MASCT-I B +Camrelizumab+Apatinib, the administration schedules for MASCT-I is different between two groups. A total of 20 patients were planned to be recruited in part A. In part B, patients will be treated with MASCT-I (based on the administration schedule selected from part A) in combination with Apatinib. 40 patients were planned to be recruited in part B. MASCT-I A and MASCT-I B were administered mainly at different frequencies.

Conditions

• Sarcoma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	MASCT-I, Camrelizumab,Apatinib	Multi-Antigen Stimulated Cell Therapy-I Injection (MASCT-I) is a sequential immune cell therapy. Camrelizumab is an immune checkpoint inhibitors against PD-1. Apatinib is a highly selective tyrosine kinase inhibitor targeting VEGFR2.

Timeline

• Start date: 2019-11-22
• Primary completion: 2024-08-07
• Completion: 2024-12-05
• First posted: 2019-08-30
• Last updated: 2023-10-23

Locations

1 site across 1 country: China