Using Plasmodium immunotherapy to treat advanced cancers

Clinical Study of Plasmodium Immunotherapy for Advanced Cancers

This study is testing a new treatment using a malaria vaccine to see if it can help people with advanced cancers feel better and improve their health.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: CAS Lamvac Biotech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT03375983 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and preliminary effectiveness of Plasmodium immunotherapy in patients with advanced cancers. It involves vaccinating patients with P. vivax-infected red blood cells and monitoring their response over a treatment period of 3-6 months. Researchers will observe various clinical symptoms, immune responses, and tumor-related parameters throughout the treatment. The study will enroll 20 patients and will conclude treatment with antimalarial drugs to terminate the Plasmodium infection.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with advanced cancers that are measurable and confirmed by histopathology.

Not a fit: Patients with nasopharyngeal carcinoma, lymphatic cancer, cervical cancer, or melanoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel immunotherapy option for patients with advanced cancers.

How similar studies have performed: While the use of Plasmodium for immunotherapy is a novel approach, similar immunotherapeutic strategies have shown promise in other contexts.

Eligibility criteria

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);
* All the patients who have not received surgery, radiotherapy, chemotherapy or targeted drug therapy and refuse to accept the above treatments must meet all the remaining requirements that listed in the inclusion criteria;
* 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;
* Women of childbearing age with positive result for pregnancy tests;
* Any condition that makes the subject ineligible to participate (in the opinion of the investigator).

Where this trial is running

Guangzhou, Guangdong

• Guangzhou Fuda Tumor Hospital — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Li Qin, M.D

Conditions Advanced Cancers; Advanced cancer; Plasmodium immunotherapy; Plasmodiun vivax