Plasmodium Immunotherapy for Advanced Cancers

NCT03375983 | Recruiting Phase 1

• 1 other identifier: ZKLH-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of Plasmodium immunotherapy and preliminarily evaluate the effectiveness of Plasmodium immunotherapy for advanced cancers.The treatment will last 3-6 months from the day of successful infection and will be terminated by antimalarial drugs.

Conditions

Advanced Cancers

Keywords

Advanced cancer; Plasmodium immunotherapy; Plasmodiun vivax

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by NCI CTCAE 4.0

  Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.

  2 years

Secondary Outcomes (8)

• Progression free survival

  2 years

• Overall survival

  2 years

• Tumor marker level

  2 years

• Objective response rate (ORR)

  2 years

• the Score of Quality of life

  2 years

Study Arms (1)

Blood-stage infection of P.vivax

EXPERIMENTAL

This is a single arm study that plans to enroll 20 patients and each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1.0 × 10\^7 Plasmodium parasites. And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last 3-6 months from the day of successful infection and will be terminated by antimalarial drugs.

Biological: Blood-stage infection of P.vivax

Interventions

Blood-stage infection of P.vivax BIOLOGICAL

The P. vivax infected blood will be confirmed to follow the national standard of blood donation to ensure that only P. vivax is included, excluding the presence of P. falciparum. Exclude other infectious diseases according to the test of national standard of blood donation.

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:

• 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);
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• CAS Lamvac Biotech Co., Ltd.: lead

Study Sites (1)

Guangzhou Fuda Tumor Hospital

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (4)

• 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

Related Links

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Central Study Contacts

Li Qin, M.D

CONTACT

0086-18802043960; njlf@cas-lamvac.com

Suyi Zhang, M.D

CONTACT

0086-20-82258805; zhang_suyi@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: December 10, 2017
• First Posted: December 18, 2017
• Study Start: November 23, 2017
• Primary Completion: March 31, 2023
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

CN (1)