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Plasmodium Immunotherapy for Advanced Cancers | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

Plasmodium Immunotherapy for Advanced Cancers

Clinical Study of Plasmodium Immunotherapy for Advanced Cancers

NCT03375983•CAS Lamvac Biotech Co., Ltd.

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).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•18-70 years of age, male or female.
•Patients with advanced cancer confirmed by histopathology and imaging; and imaging lesions of the tumor are clear and measurable, including but not limited to colon cancer, breast cancer, liver cancer, lung cancer, gastric cancer,sarcoma and other solid tumors (except for nasopharyngeal carcinoma, lymphatic cancer, cervical cancer and melanoma).
•The time interval of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 3 months for patients who had received chemotherapy (including interventional chemotherapy) or radiotherapy; at least 5 half-life for patients who had received targeted drug therapy (the half-life of targeted drug is according to the drug instructions);
•ECGO score of 0 or 1;
•Expected survival ≥ 6 months;
•PLT ≥100× 10\^9/L, NE ≥ 1.5 × 10\^9/L, and HGB ≥ 100 g/L; no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.);
•The peripheral blood count of immune cells is close to normal or normal, the immune function test result is close to or at the level of normal population, and the function of heart, lung, liver and kidney are basically normal (the liver function classification of Child-push is A or B, Cr≤1.5×ULN);
•Patient compliance meets the need for follow-up;
•The subjects are able to understand and sign informed consent.

Exclusion Criteria

•Patients with severe hemoglobin disease or severe G6PD deficiency;
•Patients with splenectomy or splenomegaly;
•Patients with drug addiction or alcohol dependence;
•With the following diseases or conditions: newly diagnosed with CNS metastasis ( excluding that the tumor lesions of the CNS has disappeared after treatment) and serious or uncontrolled systemic disease or any unstable systemic diseases (including but not limited to active infection, grade three hypertension, unstable angina, congestive heart failure, class III or IV heart disease, severe arrhythmia, liver and kidney dysfunction or metabolic disease), a clear history of neurological or psychiatric disorders, etc;
•Accept any other anti-tumor treatment at the same time;
•Patients with significantly lower immune function than those in the normal population;
•Lung function is seriously damaged, the MNW \<39% or can't get out of bed, still feel short of breath when resting;
•Rough cough, dyspnea, without normal diet or difficult to cooperate;
•Poor body condition, the researchers assess that the patients can't tolerate the immune therapy;
•Pregnant or lactating women;
+2 more criteria

Locations (1)

Guangzhou Fuda Tumor Hospital

Guangzhou, Guangdong, China

Key Dates

Start Date

November 23, 2017

Primary Completion Date

March 31, 2023

Completion Date

July 31, 2026

Last Updated

February 20, 2024

Enrollment

ESTIMATED participants

Conditions

Advanced Cancers

Interventions

Blood-stage infection of P.vivax

BIOLOGICAL

Contacts

Li Qin, M.D

CONTACT

0086-18802043960 njlf@cas-lamvac.com

Suyi Zhang, M.D

CONTACT

0086-20-82258805 zhang_suyi@cas-lamvac.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 20, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Plasmodium Immunotherapy for Advanced Cancers

Inclusion Criteria

Exclusion Criteria

Clinical Trial of TQB2922 Injection (Subcutaneous Injection) in Patients With Advanced Cancers

A Clinical Study of TQB3107 Tablets in Patients With Malignant Tumors

Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors

A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors

Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer

Sirolimus or Vorinostat and Hydroxychloroquine in Advanced Cancer