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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Plasmodium Immunotherapy for Advanced Malignant Solid Tumors

Clinical Study of Plasmodium Immunotherapy for Advanced Malignant Solid Tumors

Plasmodium Immunotherapy for Advanced Malignant Solid Tumors (NCT04165590) is a Phase 1 / Phase 2 interventional studying Advanced Malignant Solid Tumor, sponsored by CAS Lamvac Biotech Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Malignant Solid Tumor, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Malignant Solid Tumor subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Aged 18-70 years male or female. 2. Patients with advanced maligant solid tumors in lung, liver, prostate, ovary, brain, thyroid and colorectum, etc. 3. Patients with primary central nervous system (CNS) tumor or brain metastases from solid tumors, comply with the following standards can participate in this study: Up to the clinical trial screening period, the imageological examination provides progression-free evidence for at least 3 months, blood brain barrier has not been damaged or is already recovered from the former treatment (surgery or radiotherapy) injury, without intracranial hemorrhage or myelorrhagia history, without metastases to the brain stem, midbrain, pons, medulla oblongata or eye subsidiary organs within 10 mm area (the optic nerve and optic chiasma). 4. The patients have measurable tumors based on the criterion of RECIST1.1. 5. Tumor classification should be determined by histopathology and pathological report should be provided. If tumor tissue is available, before participating in the trail, the research center need to obtain the paraffin blocks or at least 6 unstained sections of the tumor tissue and the relevant pathological reports. If the above tumor tissue samples are not available, samples of any kind (such as fine needle aspiration biopsy samples, cell mass samples (such as pleural, peritoneal effusion samples and lavage samples) are acceptable. If tumor tissue is not available, patients are still eligible for the study. 6. For the patients who previously received one or more of the following therapies, the interval time of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 28 days for patients who had received chemotherapy or radiotherapy; at least 5 half-life time for patients who had received targeted drug therapy (the half-life of targeted drug is according to the drug instructions). 7. ECGO score is 0 to 2, and euphagia. 8. Expected survival ≥ 3 months. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Aged 18-70 years male or female. 2. Patients with advanced maligant solid tumors in lung, liver, prostate, ovary, brain, thyroid and colorectum, etc. 3. Patients with primary central nervous system (CNS) tumor or brain metastases from solid tumors, comply with the following standards can participate in this study: Up to the clinical trial screening period, the imageological examination provides progression-free evidence for at least 3 months, blood brain barrier has not been damaged or is already recovered from the former treatment (surgery or radiotherapy) injury, without intracranial hemorrhage or myelorrhagia history, without metastases to the brain stem, midbrain, pons, medulla oblongata or eye subsidiary organs within 10 mm area (the optic nerve and optic chiasma). 4. The patients have measurable tumors based on the criterion of RECIST1.1. 5. Tumor classification should be determined by histopathology and pathological report should be provided. If tumor tissue is available, before participating in the trail, the research center need to obtain the paraffin blocks or at least 6 unstained sections of the tumor tissue and the relevant pathological reports. If the above tumor tissue samples are not available, samples of any kind (such as fine needle aspiration biopsy samples, cell mass samples (such as pleural, peritoneal effusion samples and lavage samples) are acceptable. If tumor tissue is not available, patients are still eligible for the study. 6. For the patients who previously received one or more of the following therapies, the interval time of the termination of chemotherapy (including interventional chemotherapy) or radiotherapy is at least 28 days for patients who had received chemotherapy or radiotherapy; at least 5 half-life time for patients who had received targeted drug therapy (the half-life of targeted drug is according to the drug instructions). 7. ECGO score is 0 to 2, and euphagia. 8. Expected survival ≥ 3 months. 9. WBC≥3× 10\^9/L, PLT ≥ 100× 10\^9/L, HGB ≥ 100 g/L, and albumin ≥ 30 g/L, no significant morphological abnormalities of red blood cells, or anemia (iron deficiency anemia, autoimmune hemolytic anemia, thalassemia, etc.). 10. Patients with gastrointestinal bleeding, hemoptysis or other chronic bleeding symptoms were cured before enrollment. 11. Patients with no severe dysfunction of cardiopulmonary, liver and kidney function (child-push grading of liver function A or B, Cr≤ 1.5 x ULN). 12. Patient will be able to understand and sign informed consent. 13. According to the researcher's judgment, the patient's compliance could meet the needs of follow-up. Exclusion Criteria: 1. Nasopharyngeal cancer, head and neck tumors. 2. HPV positive patients with advanced malignant solid tumors in cervical, anal, vulvar, vaginal and penile. 3. Pancreatic cancer patients. 4. Small cell lung cancer patients. 5. Patients with severe hemoglobin disease or severe G6PD deficiency. 6. Patients with splenectomy or splenomegaly. 7. Patients with drug addiction or alcohol dependence. 8. Have not yet been washed out from the previous therapeutic effects, except the following: the bisphosphonates used for bone metastasis or osteoporosis. 9. Uncontrolled pleural effusion, pericardial effusion or ascites. 10. Tumor-related pain that are uncontrollable. 11. Active malignant tumor metastasis of CNS (progression or controlling the symptoms with anticonvulsants or corticosteroids ). 12. Patients with significant immunodeficiency detection ( CD4+T cell absolute count \<200 /ul) 13. 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. 14. According to the principal investigator's judgment, any other diseases, metabolic disorders, abnormal results of clinical laboratory tests or physical examination, the diseases that leading to usage of the prohibited drugs, influencing the results reliability, putting patients in high risk. 15. Have undergone major surgery within 4 weeks of the screening period, or plan to undergo major surgery during the study period, PICC catheter and central venous catheter implantation are excluded. 16. Received any antineoplastic drugs, immune cells, antibodies, or vaccines within five drug half-life (not sure the half-life, will be subject to two weeks) during the screening period. 17. Patients who have previously received allogeneic bone marrow transplantation or solid organ transplantation. 18. Receiving any other anti-tumor treatment at the same time. 19. Lung function is seriously damaged, the MNW \<39% or can't get out of bed, still feel short of breath when resting. 20. Rough cough, dyspnea, without normal diet or difficult to cooperate. 21. Poor body condition, the researchers assess that the patients can't tolerate the Plasmodium immunotherapy. 22. Pregnant or lactating women. 23. Patients that are unable to comply with the research and follow-up procedure. 24. Any case that the researchers believe that the patient does not suit for this clinical study.

Treatments Being Tested

OTHER

Plasmodium immunotherapy

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

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Yunnan Kungang Hospital
Kunming, Yunnan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04165590), the sponsor (CAS Lamvac Biotech Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04165590 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04165590?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04165590?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04165590. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04165590. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.