Plasmodium Immunotherapy for Advanced Ovarian Cancer

NCT05924776 | Not Yet Recruiting Phase 2

• 1 other identifier: NFYKDX-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to evaluate the safety and effectiveness of Plasmodium immunotherapy in the treatment of advanced ovarian cancer. This study plans to enroll 30 patients with advanced ovarian cancer. Each patient is inoculated with Plasmodium vivax 1-5 × 10\^6, observe the time when the parasite is detected in the peripheral blood of the subjects after the inoculation of Plasmodium, the change of the parasite density in the peripheral blood of the whole treatment cycle and the control effect of the drug on the parasite density, the main clinical symptoms and signs, laboratory test indicators, immunological test indicators and changes in the quality of life. To evaluate the safety and tolerance of the subjects to Plasmodium immunotherapy, as well as the changes of tumor related indicators and immunological indicators.

Conditions

Advanced Ovarian Cancer

Keywords

Advanced ovarian cancer; Plasmodium immunotherapy; Plasmodium vivax

Outcome Measures

Primary Outcomes (7)

• Objective response rate（ORR）

  The proportion of patients whose tumors shrink to a certain amount and remain for a certain time.

  2 years

• 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

• Disease control rate (DCR)

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

  2 years

• 1-year survival rate

  The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated \* 100%.

  1 years

• 2-year survival rate

  The number of cancer cases remaining after 2 years of treatment / the total number of cancer cases treated \* 100%.

  2 years

• Overall survival (OS)

  The time starting from the treatment to death of whatever causes (when subjects have lost for follow-up before death, the last follow-up time will be calculated as the time of death).

  2 years

• Tumor marker level

  The patient's sensitive tumor markers will be reviewed periodically from the time they are enrolled into the study. The tumor markers include Carcinoembryonic antigen（CEA）, Carbohydrate Antigen 125（CA125）, human epididymis protein 4（HE4）, alpha-fetal protein（AFP）, neuron-specific enolase（NSE）, Carbohydrate Antigen 199（CA199）.

  2 years

Secondary Outcomes (2)

• Incidence of adverse events (AE) and serious adverse events (SAE)

  2 years

• Pain score

  2 years

Other Outcomes (1)

• Immunological indicators

  2 years

Study Arms (1)

Plasmodium immunotherapy group

EXPERIMENTAL

This is a single arm study that is planed to enroll 30 patients with advanced ovarian cancer and each patient will be inoculated with P.vivax-infected red blood cells containing approximately 1-5 × 10\^6 Plasmodium parasites. And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples. The treatment will last 6 weeks from the day of successful infection and will be terminated by antimalarial drugs.

Biological: Plasmodium immunotherapy

Interventions

Plasmodium immunotherapy BIOLOGICAL

Inoculation 1-5 × 10\^6 Plasmodium vivax once

Plasmodium immunotherapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old(including the threshold), female;
• The patients with ovarian cancer, who has been diagnosed by histopathological examination, can provide pathological reports, and is classified as stage III or stage IV according to the American Joint Committee on Cancer (AJCC) ovarian cancer staging version 8 (2017);
• Platinum-resistant patient who has received at least the first line of platinum-containing standard chemotherapy (refer to China's Guidelines for the Diagnosis and Treatment of Ovarian Cancer (2022)) in the past, and have been evaluated as disease progression by objective imaging;
• According to the evaluation standard of solid tumor efficacy RECIST 1.1, the therapeutic effect can be evaluated if there is ≥ 1 measurable lesion or continuous positive tumor marker;
• There are no plans and requirements for receiving other anti-tumor treatment during the treatment of Plasmodium immunotherapy;
• The score of Eastern Cooperative Oncology Group(ECOG) is 0-1;
• Expected survival time ≥ 3 months;
• If no platelets or red blood cells are transfused within 14 days before screening, and no thrombopoietin (TPO), granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), interleukin 11 (IL-11) or other drugs are used to correct abnormal blood picture: neutrophil (NEUM) ≥ 1.5 × 10\^9/L, platelet (PLT) ≥ 100 × 10\^9/L, hemoglobin (HGB) ≥ 90g/L, no obvious abnormality of erythrocyte morphology; Albumin (ALB) ≥ 35g/L;
• For female subjects with the possibility of pregnancy: from the time of signing the informed consent form (ICF) to the end of Plasmodium immunotherapy treatment at least 24 weeks, consent to abstinence or use of effective contraceptive methods, including intrauterine devices, etc. (Note: women of childbearing age have undergone surgical sterilization (including hysterectomy, bilateral oophorectomy or total hysterectomy), or have menopause for more than 24 menstrual cycles, That is, there is no possibility of pregnancy);
• Subjects are fully capable of understanding and signing the informed consent form.

You may not qualify if:

• Subjects who have any of the following conditions cannot be included in the study:
• Have received any investigational drug within 4 weeks before the first inoculation of Plasmodium parasite, or have participated in another clinical study at the same time (except that the subjects have participated in the observational and non-interventive clinical study, or are in the follow-up period of the intervention clinical study);
• Immunodeficiency diseases, including HIV infection, other acquired and congenital immunodeficiency diseases;
• Coagulation dysfunction, or acute or chronic hemorrhagic disease;
• Have received other anti-tumor treatment in the past, and the period from the termination of treatment to the screening is less than 14 days or 5 half-lives (whichever occurs first);
• The time interval between radiotherapy and treatment in this study for patients who have previously received external or internal radiotherapy is less than 28 days;
• Patients with severe hemoglobinopathy or severe Glucose-6-Phosphate Dehydrogenase(G6PD) deficiency;
• After splenectomy or splenomegaly;
• Drug addicts or alcohol addicts;
• Plenty of pleural effusion, pericardial effusion or ascites;
• Patients with active hepatitis B or hepatitis C;
• Patients with obvious defects in immunocyte classification test (CD4+T cell absolute count\<200/ μ l）； Or receive any form of immunosuppressive treatment within 28 days before the trial treatment;
• Have serious or uncontrolled systemic diseases (including but not limited to active infection, grade III hypertension, unstable angina pectoris, congestive heart failure, grade III or IV heart disease, serious arrhythmia, liver and kidney insufficiency, myocardial infarction, etc.);
• Currently has mental disorder or a history of mental illness;
• Having undergone major surgery within three months from the screening period;

Sponsors & Collaborators

• CAS Lamvac (Guangzhou) Biomedical Technology Co., Ltd.: lead
• The Third Affiliated Hospital of Southern Medical University: collaborator

Study Sites (1)

The Third Affiliated Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Malaria, Vivax

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Officials

• Guo Shuiqun, Ph.D., M.D.

  The Third Affiliated Hospital of Southern Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia Shuqi, B.S.

CONTACT

86-13602467407; xia_shuqi@cas-lamvac.com

Cao Jiazhen, B.S.

CONTACT

86-18520532361; cao_jiazhen@cas-lamvac.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2023
• First Posted: June 29, 2023
• Study Start: July 20, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 30, 2029
• Last Updated: July 22, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)