Neoplasms

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Artesunate

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Artemisinin

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Chloroquine diphosphate

This is a single arm study that enrolls 30 patients to receive Plasmodium immunotherapy.

Each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1×10\^7 Plasmodium parasites.And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples.The treatment will last at least 12 weeks from the day of finding the Plasmodium from peripheral blood and will be terminated by chloroquine phosphate or Artemisinin compound preparation or Artesunate injection.

Blood-stage infection of P. vivax

Chengzhi Zhou, M.D.

Ming Ou-Yang, M.D.

The objective of this study is to evaluate the safety and the effectiveness of Plasmodium immunotherapy (blood-stage infection of Plasmodium vivax) for advanced non-small cell lung cancer.The treatment will last 3-6 months from the day of successful infection and will be terminated by antimalarial drugs.

In our study，30 patients with stage III/IV NSCLC will be enrolled to receive vaccination with an optimal concentration and amount of blood-stage P. vivax to observe the infection time, rate and cycle; principal clinical symptoms such as fever and anemia; heart, liver and kidney function; changes in spleen morphology and function, and dynamic changes in the function of peripheral immune cells. Moreover, the patient's tolerance to Plasmodium infection and changes in tumor-related parameters will be observed.

The duration of the planned treatment is 3-6 months, and successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last at least 12 weeks from the day of finding the Plasmodium from peripheral blood and will be terminated by chloroquine phosphate or Artemisinin compound preparation or Artesunate injection. Each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1×10\^7 Plasmodium parasites. After vaccination, the onset and duration of peripheral parasitemia and the infection rate; principal clinical symptoms such as Chills, fever, pain (headache, joint pain, etc.), digestive tract reaction;peripheral hemogram changes；heart, liver and kidney function; changes in lung function, and dynamic changes in the function of peripheral immune cells will be observed. Moreover, the patient's tolerance to Plasmodium infection and changes in tumor-related parameters will be observed.

Plasmodium Immunotherapy for Lung Cancer

Clinical Study of Plasmodium Immunotherapy for Advanced Non-small Cell Lung Cancer

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

The time starting from the research to tumor progression.

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 year 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 cytometry.

CAS Lamvac Biotech Co., Ltd.

State Key Laboratory of Respiratory Disease

Associate Chief Physician

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

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

Antimalarials

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 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%.

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 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Plasmodium Immunotherapy for Lung Cancer	NCT02786589	Lung Cancer, No...	Blood-stage inf...	18 Years - 70 Years	State Key Laboratory of Respiratory Disease
Plasmodium Immunotherapy for Advanced Ovarian Cancer	NCT05924776	Advanced Ovaria...	Plasmodium immu...	18 Years - 80 Years	CAS Lamvac Biotech Co., Ltd.
Plasmodium Immunotherapy for Lung Cancer	NCT02786589	Lung Cancer, No...	Blood-stage inf...	18 Years - 70 Years	State Key Laboratory of Respiratory Disease

Spots Global Cancer Trial Database for plasmodium vivax