Infections

All Conditions

Symptoms and General Pathology

Rare Diseases

Malaria

Communicable Diseases

Protozoan Infections

Parasitic Diseases

Mosquito-Borne Diseases

Vector Borne Diseases

All Drugs and Chemicals

Anti-Infective Agents

Immunomodulating Agents

Antimalarials

This is a single arm study that plans to enroll 20 patients and each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1.0 × 10\^7 Plasmodium parasites. And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last 3-6 months from the day of successful infection and will be terminated by antimalarial drugs.

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.

Blood-stage infection of P.vivax

Li Qin, M.D

Suyi Zhang, M.D

Weibing Zhu, M.D.

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.

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).

Plasmodium Immunotherapy for Advanced Cancers

Clinical Study of Plasmodium Immunotherapy for Advanced Cancers

Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.

Progression free survival (PFS): Starting from treatment until the disease progression is first found or the time of any cause of death (disease progression refers to tumor growth, or metastasis of primary tumor, or discovery of new lesions).

The time starting from the treatment to death of whatever causes (when subjects have lost for follow-up before death, the last follow-up time will be calculated as the time of death).

The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study.

The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.

Patients are regularly filled with QLQ-C30 (cancer patient quality of life scale) to assess the quality of life of the patients.

The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated \* 100%.

The number of cancer cases remaining after 2 years of treatment / the total number of cancer cases treated \* 100%.

Detection of absolute number of immune cells（such as CD3+CD4+、CD3+CD8+ and so on ）in peripheral blood by flow cytometry.

CAS Lamvac Biotech Co., Ltd.

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Immunologic Factors

This is a single arm study that is planed to enroll 30 patients with advanced ovarian cancer and each patient will be inoculated with P.vivax-infected red blood cells containing approximately 1-5 × 10\^6 Plasmodium parasites. And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last 6 weeks from the day of successful infection and will be terminated by antimalarial drugs.

Inoculation 1-5 × 10\^6 Plasmodium vivax once

Plasmodium immunotherapy

Xia Shuqi, B.S.

Cao Jiazhen, B.S.

Guo Shunqun, Ph.D., M.D.

Deng Yuanrun, Ph.D., M.D.

Guo Shuiqun, Ph.D., M.D.

The main purpose of this study is to evaluate the safety and effectiveness of Plasmodium immunotherapy in the treatment of advanced ovarian cancer. This study plans to enroll 30 patients with advanced ovarian cancer. Each patient is inoculated with Plasmodium vivax 1-5 × 10\^6, observe the time when the parasite is detected in the peripheral blood of the subjects after the inoculation of Plasmodium, the change of the parasite density in the peripheral blood of the whole treatment cycle and the control effect of the drug on the parasite density, the main clinical symptoms and signs, laboratory test indicators, immunological test indicators and changes in the quality of life. To evaluate the safety and tolerance of the subjects to Plasmodium immunotherapy, as well as the changes of tumor related indicators and immunological indicators.

Each subject who passed the screening is immunized with Plasmodium vivax 1-5 × 10\^6, observe the time when the parasite is detected in the peripheral blood of the subjects after inoculation, the change of the parasite density in the peripheral blood of the whole treatment cycle (about 6 weeks) and the control effect of the drug on the parasite density. The clinical symptoms and signs after treatment are mainly observed; Blood routine, blood biochemistry, blood coagulation, tumor markers and other laboratory test indicators change; Changes of cellular immunity and humoral immunity; Changes in quality of life. When Plasmodium infected erythrocytes among total erythrocytes (defined as the parasite density) ≥ 0.1% occurs during the test, artemisinin drugs should be used to control the parasite density below 0.1%, and symptomatic treatment should be carried out. The duration of Plasmodium immunotherapy for each subject is 6 weeks (time window, ± 1 day). The day the immunodynamic marker (Fim) is greater than baseline level is defined as the first day of Plasmodium immunotherapy. When Plasmodium immunotherapy lasts for 6 weeks (time window, ± 1 day), use antimalarial drugs to kill the parasite and terminate the treatment. After treatment, the patients are followed up for 2 years. We will carry out a follow-up visit once a month after the termination of Plasmodium infection according to the plan, and the follow-up visit in the first month, third month and sixth month is outpatient visit, which is ± 5 days in the first month and ± 7 days in the third month and sixth month respectively; Follow-up outpatient visit will be conducted every 3 months ± 10 days; The rest are telephone follow-up (once every 30 days ± 5). When the follow-up time overlaps with the previous outpatient follow-up time, no additional telephone follow-up will be conducted.

Plasmodium Immunotherapy for Advanced Ovarian Cancer

Clinical Study of Plasmodium Immunotherapy for Advanced Ovarian Cancer

Detection of absolute number of immune cells（such as CD3+CD4+、CD3+CD8+ and so on）in peripheral blood by flow cytometry.

The proportion of patients whose tumors shrink to a certain amount and remain for a certain time.

Starting from treatment until the disease progression is first found or the time of any cause of death (disease progression refers to tumor growth, or metastasis of primary tumor, or discovery of new lesions).

The proportion of patients who had a best response rating of complete response, partial response, or stable disease.

The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study. The tumor markers include Carcinoembryonic antigen（CEA）, Carbohydrate Antigen 125（CA125）, human epididymis protein 4（HE4）, alpha-fetal protein（AFP）, neuron-specific enolase（NSE）, Carbohydrate Antigen 199（CA199）.

Any adverse medical event occurred in the subjects who participated in the clinical study and received Plasmodium immunotherapy.

Patients are regularly filled with Quality of Life Questionnaire-Core 30(QLQ-C30) to assess the quality of life of the patients.

Patients are regularly evaluated with Visual Analog Scale for Pain. The minimum value is 0, and the maximum value is 10. The higher scores mean a worse outcome.

The Third Affiliated Hospital of Southern Medical University

CAS Lamvac (Guangzhou) Biomedical Technology Co., Ltd.

Skin and Connective Tissue Diseases

Digestive System Diseases

Breast Neoplasms

Liver Neoplasms

Breast Diseases

Skin Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Liver Extracts

This is a single arm study that plans to enroll 30 patients in each type cancer and each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10\^7 Plasmodium parasites. The treatment will last 4-6 weeks from the day of successful infection and will be terminated by antimalarial drugs.

Qin Li, M.D

Zhang Su Yi, M.D

Hou Jiang Hou, M.D

The purpose of this study is to evaluate the safety and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced breast cancers and advanced liver cancers.The treatment will last 4-6 weeks from the day of successful infection and will be terminated by antimalarial drugs.

This study is to enroll 30 patients in each type of cancer. Each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 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; the changes in heart, lung, liver and kidney function. Preliminarily observe the changes in the primary and metastatic lesions of the cancer, the tolerance of patients to Plasmodium infection, changes in tumor-related parameters and immunological related parameters.The rate of the erythrocytes infected by plasmodium is controlled below 0.01% by using Artemisinin during the course, and clinical treatment is conduced according to the microscopic examination to ensure that no serious complications occurs.The duration of the planned treatment of each subject is 4-6 weeks. The time of the treatment course is based on vaccination with P.vivax-infected red blood cells. After 4-6 weeks, 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), and then the patients are followed up for 2 years.

Plasmodium Immunotherapy for Breast and Liver Cancers

Clinical Study of Plasmodium Immunotherapy for Advanced Breast Cancers and Advanced Liver Cancers

This is a single arm study that is planed to enroll 60 patients with advanced malignant solid tumor and each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10\^7 Plasmodium parasites. And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last 5-10 weeks from the day of successful infection and will be terminated by antimalarial drugs.

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

Qin Li, Ph.D

Huang Qiumei, M.D

Hou Jianghou, Ph.D

Xu Jinsong, M.D

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.

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.

Plasmodium Immunotherapy for Advanced Malignant Solid Tumors

Clinical Study of Plasmodium Immunotherapy for Advanced Malignant Solid Tumors

TTP is the time between the beginning of treatment and the onset of tumor progression.

Duration of disease control is the time from the first evaluation of the tumor as CR, PR or SD to the first evaluation as PD (progressive disease) or any cause of death.

Patients are regularly evluated with pain assessment scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Plasmodium Immunotherapy for Advanced Cancers	NCT03375983	Advanced Cancer...	Blood-stage inf...	18 Years - 70 Years	CAS Lamvac Biotech Co., Ltd.
Plasmodium Immunotherapy for Advanced Ovarian Cancer	NCT05924776	Advanced Ovaria...	Plasmodium immu...	18 Years - 80 Years	CAS Lamvac Biotech Co., Ltd.
Plasmodium Immunotherapy for Breast and Liver Cancers	NCT03474822	Advanced Breast... Advanced Liver ...	Blood-stage inf...	18 Years - 70 Years	CAS Lamvac Biotech Co., Ltd.
Plasmodium Immunotherapy for Advanced Malignant Solid Tumors	NCT04165590	Advanced Malign...	Plasmodium immu...	18 Years - 70 Years	CAS Lamvac Biotech Co., Ltd.
Plasmodium Immunotherapy for Breast and Liver Cancers	NCT03474822	Advanced Breast... Advanced Liver ...	Blood-stage inf...	18 Years - 70 Years	CAS Lamvac Biotech Co., Ltd.

Spots Global Cancer Trial Database for plasmodium immunotherapy