Advanced Ovarian CancerPhase 2/3NCT05924776
Plasmodium Immunotherapy for Advanced Ovarian Cancer
A Phase 2/3 study testing Plasmodium immunotherapy in people with Advanced Ovarian Cancer, run by CAS Lamvac (Guangzhou) Biomedical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Advanced Ovarian Cancer
- What is being tested?
- Plasmodium immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2024to 30 Mar 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all the following inclusion criteria:
- 18-80 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;
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- 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.
Who cannot join
- 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;
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- 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;
- Have received bone marrow transplantation or organ transplantation in the past;
- Moderate or severe pulmonary ventilation dysfunction;
- Those who are currently receiving regular anti-tumor treatment, and the treatment is effective or there is no obvious progress in the disease;
- The investigator evaluated the patients who could not tolerate Plasmodium immunotherapy;
- Pregnancy, lactation or pregnancy within 6 months after treatment;
- According to the judgment of the researcher, the other conditions of the subject are not suitable for participating in the test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Third Affiliated Hospital of Southern Medical University
Guangzhou, Guangdong
Guo Shunqun, Ph.D., M.D., guosq2005@126.com
Deng Yuanrun, Ph.D., M.D., 295333202@qq.com
About this study
Official title: Clinical Study of Plasmodium Immunotherapy for Advanced Ovarian Cancer
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.
Read the detailed description
Each subject who passed the screening is immunized with Plasmodium vivax 1-5 × 10^6, observe the time when the parasite is detected in the peripheral blood of the subjects after inoculation, the change of the parasite density in the peripheral blood of the whole treatment cycle (about 6 weeks) and the control effect of the drug on the parasite density. The clinical symptoms and signs after treatment are mainly observed; Blood routine, blood biochemistry, blood coagulation, tumor markers and other laboratory test indicators change; Changes of cellular immunity and humoral immunity; Changes in quality of life. When Plasmodium infected erythrocytes among total erythrocytes (defined as the parasite density) ≥ 0.1% occurs during the test, artemisinin drugs should be used to control the parasite density below 0.1%, and symptomatic treatment should be carried out. The duration of Plasmodium immunotherapy for each subject is 6 weeks (time window, ± 1 day). The day the immunodynamic marker (Fim) is greater than baseline level is defined as the first day of Plasmodium immunotherapy. When Plasmodium immunotherapy lasts for 6 weeks (time window, ± 1 day), use antimalarial drugs to kill the parasite and terminate the treatment. After treatment, the patients are followed up for 2 years. We will carry out a follow-up visit once a month after the termination of Plasmodium infection according to the plan, and the follow-up visit in the first month, third month and sixth month is outpatient visit, which is ± 5 days in the first month and ± 7 days in the third month and sixth month respectively; Follow-up outpatient visit will be conducted every 3 months ± 10 days; The rest are telephone follow-up (once every 30 days ± 5). When the follow-up time overlaps with the previous outpatient follow-up time, no additional telephone follow-up will be conducted.
- Conditions
- Advanced Ovarian Cancer
- Being tested
- Plasmodium immunotherapy
- Keywords
- Advanced ovarian cancer, Plasmodium immunotherapy, Plasmodium vivax
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasmodium immunotherapyBiological
Inoculation 1-5 × 10^6 Plasmodium vivax once
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Plasmodium immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate（ORR）
The proportion of patients whose tumors shrink to a certain amount and remain for a certain time.
Measured: 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).
Measured: 2 years
Disease control rate (DCR)
The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
Measured: 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%.
Measured: 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%.
Measured: 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).
Measured: 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）.
Measured: 2 years
Secondary outcomes (2)
Incidence of adverse events (AE) and serious adverse events (SAE)
Any adverse medical event occurred in the subjects who participated in the clinical study and received Plasmodium immunotherapy.
Measured: 2 years
Pain score
Patients are regularly evaluated with Visual Analog Scale for Pain. The minimum value is 0, and the maximum value is 10. The higher scores mean a worse outcome.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start20 Jul 2024 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAS Lamvac (Guangzhou) Biomedical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Third Affiliated Hospital of Southern Medical University
- Responsible party
- Sponsor
- Investigators
- Guo Shuiqun, Ph.D., M.D., Principal investigator, The Third Affiliated Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924776
- Sponsor's protocol ID
- NFYKDX-002
- Status last verified
- Jul 2024
- First submitted
- 19 Jun 2023
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Plasmodium Immunotherapy for Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT05924776
- Acronym / sponsor ID
- NFYKDX-002
- Conditions
- Advanced Ovarian Cancer
- Keywords
- Advanced ovarian cancer, Plasmodium immunotherapy, Plasmodium vivax
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- CAS Lamvac (Guangzhou) Biomedical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Third Affiliated Hospital of Southern Medical University
- Study start
- 20 Jul 2024 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Each subject who passed the screening is immunized with Plasmodium vivax 1-5 × 10^6, observe the time when the parasite is detected in the peripheral blood of the subjects after inoculation, the change of the parasite density in the peripheral blood of the whole treatment cycle (about 6 weeks) and the control effect of the drug on the parasite density. The clinical symptoms and signs after treatment are mainly observed; Blood routine, blood biochemistry, blood coagulation, tumor markers and other laboratory test indicators change; Changes of cellular immunity and humoral immunity; Changes in quality of life. When Plasmodium infected erythrocytes among total erythrocytes (defined as the parasite density) ≥ 0.1% occurs during the test, artemisinin drugs should be used to control the parasite density below 0.1%, and symptomatic treatment should be carried out. The duration of Plasmodium immunotherapy for each subject is 6 weeks (time window, ± 1 day). The day the immunodynamic marker (Fim) is greater than baseline level is defined as the first day of Plasmodium immunotherapy. When Plasmodium immunotherapy lasts for 6 weeks (time window, ± 1 day), use antimalarial drugs to kill the parasite and terminate the treatment. After treatment, the patients are followed up for 2 years. We will carry out a follow-up visit once a month after the termination of Plasmodium infection according to the plan, and the follow-up visit in the first month, third month and sixth month is outpatient visit, which is ± 5 days in the first month and ± 7 days in the third month and sixth month respectively; Follow-up outpatient visit will be conducted every 3 months ± 10 days; The rest are telephone follow-up (once every 30 days ± 5). When the follow-up time overlaps with the previous outpatient follow-up time, no additional telephone follow-up will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasmodium immunotherapy group | Experimental | Biological: Plasmodium immunotherapyThis 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must meet all the following inclusion criteria:
Key exclusion criteria (21 listed)
- Subjects who have any of the following conditions cannot be included in the study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasmodium immunotherapyInoculation 1-5 × 10^6 Plasmodium vivax once | Biological | Plasmodium immunotherapy group |
Primary outcome
Objective response rate（ORR）
Time frame: 2 years
The proportion of patients whose tumors shrink to a certain amount and remain for a certain time.
Progression-free survival (PFS)
Time frame: 2 years
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).
Disease control rate (DCR)
Time frame: 2 years
The proportion of patients who had a best response rating of complete response, partial response, or stable disease.
1-year survival rate
Time frame: 1 years
The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated * 100%.
2-year survival rate
Time frame: 2 years
The number of cancer cases remaining after 2 years of treatment / the total number of cancer cases treated * 100%.
Overall survival (OS)
Time frame: 2 years
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).
Tumor marker level
Time frame: 2 years
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 secondary outcomes
Incidence of adverse events (AE) and serious adverse events (SAE)
Time frame: 2 years
Pain score
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guo Shuiqun, Ph.D., M.D. principal investigator
The Third Affiliated Hospital of Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Plasmodium immunotherapy in people with Advanced Ovarian Cancer, run by CAS Lamvac (Guangzhou) Biomedical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xia Shuqi, B.S. (86-13602467407, xia_shuqi@cas-lamvac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate（ORR） (time frame: 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.