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Plasmodium Immunotherapy for Advanced Malignant Solid Tumors

ConditionAdvanced Malignant Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCAS Lamvac Biotech Co., Ltd.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-70 years male or female.

Patients with advanced maligant solid tumors in lung, liver, prostate, ovary, brain, thyroid and colorectum, etc.

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).

The patients have measurable tumors based on the criterion of RECIST1.1.

Disqualifiers

Nasopharyngeal cancer, head and neck tumors.

HPV positive patients with advanced malignant solid tumors in cervical, anal, vulvar, vaginal and penile.

Pancreatic cancer patients.

Small cell lung cancer patients.

Trial design

Design model

Single group

Treatments tested in this trial

  • Plasmodium immunotherapy

    Other intervention

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

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Blood-stage infection of P.vivaxExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
2 years

Secondary outcomes

1

Tumor marker level

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

Time frame
2 years
2

Disease Control Rate

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

Time frame
2 years
3

Immunological index

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

Time frame
2 years
4

Quality of life score

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

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CAS Lamvac Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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