NCT04165590

Plasmodium Immunotherapy for Advanced Malignant Solid Tumors

Clinical Study of Plasmodium Immunotherapy for Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CAS Lamvac Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is: 1) to evaluate the effectiveness and extended safety of the Plasmodium immunotherapy for the advanced malignant solid tumors. 2) To explore the safe and effective course of the Plasmodium immunotherapy for the advanced malignant solid tumors. 3) To explore the possible indications of Plasmodium immunotherapy for advanced malignant solid tumors. The treatment will last 5-10 weeks from the day of successful infection and will be terminated by antimalarial drugs.

Detailed description

This study is planed to enroll 60 patients. Each patient will be vaccinated with 2 ml of P. vivax-infected red blood cells, containing approximately 0.1-1.0 × 10\^7 Plasmodium parasites. The treatment will last for 5-10 weeks from the day of successful infection. During the period of Plasmodium immunotherapy, doctor will use artesunate to control the P. vivax erythrocyte infection rate at a low level, so as to prevent the severe adverse event. After 5-10 weeks, parasitemia will be terminated by antimalarial drugs for ending the treatment of Plasmodium immunotherapy (the immunological treatment effect may persist after the termination of Plasmodium infection). After the treatment, patients will be followed up for 2 years.

Conditions

• Advanced Malignant Solid Tumor

Interventions

Type	Name	Description
OTHER	Plasmodium immunotherapy	The patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.1-1.0 × 10\^7 Plasmodium parasites.

Timeline

• Start date: 2019-10-24
• Primary completion: 2024-04-30
• Completion: 2026-10-31
• First posted: 2019-11-18
• Last updated: 2024-02-20

Locations

1 site across 1 country: China