Using Plasmodium immunotherapy to treat advanced breast and liver cancers

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

This study is testing a new immunotherapy using malaria-infected blood cells to see if it can help people with advanced breast and liver cancers.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: CAS Lamvac Biotech Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT03474822 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and preliminary effectiveness of Plasmodium immunotherapy in patients with advanced breast and liver cancers. The study involves vaccinating patients with P.vivax-infected red blood cells and monitoring their response over a treatment period of 4-6 weeks. Participants will be observed for infection parameters, clinical symptoms, and changes in tumor-related and immunological parameters. Following the treatment, patients will be followed up for two years to assess long-term effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with advanced breast or liver cancer who have previously received standard therapies.

Not a fit: Patients with early-stage cancers or those who have not undergone any prior cancer treatment 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 breast and liver 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, though this specific application is largely untested.

Eligibility criteria

Inclusion Criteria:

* 18-70 years of age, male or female.
* Patients with advanced breast cancer and advanced liver cancer confirmed by histopathology and imaging; and imaging lesions of the tumor are clear and measurable.
* Previously received at least one standard therapy.
* The time interval of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 1 months for patients who had received 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: 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.
* Advanced liver cancer patients with severe varicose vein in the esophagus.
* 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 case that researchers believe that the patient does not suit for this clinical study.

Where this trial is running

Guangzhou, Guangdong

• Plasmodiun vivax — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Qin Li, M.D

Conditions: Advanced Breast Cancer, Advanced Liver Cancer, Advanced breast cancer, advanced liver cancer, Plasmodium immunotherapy, Plasmodiun vivax