Plasmodium Immunotherapy for Advanced Malignant Solid Tumors

NCT04165590 | Recruiting Phase 1

• 1 other identifier: KGYY-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced Malignant Solid Tumor

Keywords

advanced malignant solid tumor; Plasmodium immunotherapy; Plasmodiun vivax

Outcome Measures

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).

  2 years

Secondary Outcomes (10)

• Tumor marker level

  2 years

• Disease Control Rate

  2 years

• Immunological index

  2 years

• Quality of life score

  2 years

• Overall survival

  2 years

Study Arms (1)

Blood-stage infection of P.vivax

EXPERIMENTAL

This is a single arm study that is planed to enroll 60 patients with advanced malignant solid tumor and each patient will be vaccinated with P.vivax-infected red blood cells containing approximately 0.1-1.0 × 10\^7 Plasmodium parasites. And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last 5-10 weeks from the day of successful infection and will be terminated by antimalarial drugs.

Other: Plasmodium immunotherapy

Interventions

Plasmodium immunotherapy OTHER

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

Blood-stage infection of P.vivax

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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).
• ECGO score is 0 to 2, and euphagia.
• Expected survival ≥ 3 months.
• 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.).
• Patients with gastrointestinal bleeding, hemoptysis or other chronic bleeding symptoms were cured before enrollment.
• 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).
• Patient will be able to understand and sign informed consent.
• According to the researcher's judgment, the patient's compliance could meet the needs of follow-up.

You may not qualify if:

• 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.
• Patients with severe hemoglobin disease or severe G6PD deficiency.
• Patients with splenectomy or splenomegaly.
• Patients with drug addiction or alcohol dependence.
• Have not yet been washed out from the previous therapeutic effects, except the following: the bisphosphonates used for bone metastasis or osteoporosis.
• Uncontrolled pleural effusion, pericardial effusion or ascites.
• Tumor-related pain that are uncontrollable.
• Active malignant tumor metastasis of CNS (progression or controlling the symptoms with anticonvulsants or corticosteroids ).
• Patients with significant immunodeficiency detection ( CD4+T cell absolute count \<200 /ul)
• 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.
• 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.
• 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.

Sponsors & Collaborators

• CAS Lamvac Biotech Co., Ltd.: lead

Study Sites (1)

Yunnan Kungang Hospital

Kunming, Yunnan, 650000, China

RECRUITING

Related Publications (5)

• Chen L, He Z, Qin L, Li Q, Shi X, Zhao S, Chen L, Zhong N, Chen X. Antitumor effect of malaria parasite infection in a murine Lewis lung cancer model through induction of innate and adaptive immunity. PLoS One. 2011;6(9):e24407. doi: 10.1371/journal.pone.0024407. Epub 2011 Sep 9.

  PMID: 21931708 RESULT

• Qin L, Chen C, Chen L, Xue R, Ou-Yang M, Zhou C, Zhao S, He Z, Xia Y, He J, Liu P, Zhong N, Chen X. Worldwide malaria incidence and cancer mortality are inversely associated. Infect Agent Cancer. 2017 Feb 14;12:14. doi: 10.1186/s13027-017-0117-x. eCollection 2017.

  PMID: 28228842 RESULT

• Yang Y, Liu Q, Lu J, Adah D, Yu S, Zhao S, Yao Y, Qin L, Qin L, Chen X. Exosomes from Plasmodium-infected hosts inhibit tumor angiogenesis in a murine Lewis lung cancer model. Oncogenesis. 2017 Jun 26;6(6):e351. doi: 10.1038/oncsis.2017.52.

  PMID: 28650446 RESULT

• Liu Q, Yang Y, Tan X, Tao Z, Adah D, Yu S, Lu J, Zhao S, Qin L, Qin L, Chen X. Plasmodium parasite as an effective hepatocellular carcinoma antigen glypican-3 delivery vector. Oncotarget. 2017 Apr 11;8(15):24785-24796. doi: 10.18632/oncotarget.15806.

  PMID: 28445973 RESULT

• Adah D, Yang Y, Liu Q, Gadidasu K, Tao Z, Yu S, Dai L, Li X, Zhao S, Qin L, Qin L, Chen X. Plasmodium infection inhibits the expansion and activation of MDSCs and Tregs in the tumor microenvironment in a murine Lewis lung cancer model. Cell Commun Signal. 2019 Apr 12;17(1):32. doi: 10.1186/s12964-019-0342-6.

  PMID: 30979375 RESULT

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Study Officials

• Hou Jianghou, Ph.D

  Yunnan Kungang Hospital

  STUDY DIRECTOR

Central Study Contacts

Qin Li, Ph.D

CONTACT

0086-18802043960; qin_li@cas-lamvac.com

Huang Qiumei, M.D

CONTACT

0086-20-82258809; huang_qiumei@cas-lamvac.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: October 24, 2019
• Primary Completion: April 30, 2024
• Study Completion (Estimated): October 31, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)