NCT03375983

Plasmodium Immunotherapy for Advanced Cancers

Clinical Study of Plasmodium Immunotherapy for Advanced Cancers

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (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 to evaluate the safety of Plasmodium immunotherapy and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced cancers.The treatment will last 3-6 months from the day of successful infection and will be terminated by antimalarial drugs.

Detailed description

This study is to enroll 20 patients. Each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1.0 × 10\^7 Plasmodium parasites and be observed for the exact infection time, parasitemia condition and infection course; principal clinical symptoms such as fever; gastrointestinal reaction; peripheral blood parameters;heart, liver and kidney function; changes in lung function, and dynamic changes in the function of peripheral immune cells. Moreover, the tolerance of patients to Plasmodium infection and changes in tumor-related parameters will be observed preliminarily.The duration of the planned treatment of each subject is 3-6 months. Since the successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples, the time of the treatment course is based on the presence of peripheral parasitemia. After 3-6 months, parasitemia will be terminated by antimalarial drugs for terminating the treatment of Plasmodium immunotherapy ( the immunological treatment effect may persist after the termination of Plasmodium infection).

Conditions

• Advanced Cancers

Interventions

Type	Name	Description
BIOLOGICAL	Blood-stage infection of P.vivax	The P. vivax infected blood will be confirmed to follow the national standard of blood donation to ensure that only P. vivax is included, excluding the presence of P. falciparum. Exclude other infectious diseases according to the test of national standard of blood donation.

Timeline

• Start date: 2017-11-23
• Primary completion: 2023-03-31
• Completion: 2026-07-31
• First posted: 2017-12-18
• Last updated: 2024-02-20

Locations

1 site across 1 country: China