Advanced CancersPhase 1/2NCT03375983
Plasmodium Immunotherapy for Advanced Cancers
A Phase 1/2 study testing Blood-stage infection of P.vivax in people with Advanced Cancers, run by CAS Lamvac Biotech Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- Blood-stage infection of P.vivax
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2017to 31 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 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);
- All the patients who have not received surgery, radiotherapy, chemotherapy or targeted drug therapy and refuse to accept the above treatments must meet all the remaining requirements that listed in the inclusion criteria;
- ECGO score of 0 or 1;
- Expected survival ≥ 6 months;
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou Fuda Tumor Hospital
Guangzhou, Guangdong, 510000
Weibing Zhu, M.D., 86 20 38993978, fuda2@fudahospital.com
About this study
Official title: Clinical Study of Plasmodium Immunotherapy for Advanced Cancers
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.
Read the detailed description
This study is to enroll 20 patients. Each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1.0 × 10^7 Plasmodium parasites and be observed for the exact infection time, parasitemia condition and infection course; principal clinical symptoms such as fever; gastrointestinal reaction; peripheral blood parameters;heart, liver and kidney function; changes in lung function, and dynamic changes in the function of peripheral immune cells. Moreover, the tolerance of patients to Plasmodium infection and changes in tumor-related parameters will be observed preliminarily.The duration of the planned treatment of each subject is 3-6 months. Since the successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples, the time of the treatment course is based on the presence of peripheral parasitemia. After 3-6 months, parasitemia will be terminated by antimalarial drugs for terminating the treatment of Plasmodium immunotherapy ( the immunological treatment effect may persist after the termination of Plasmodium infection).
- Conditions
- Advanced Cancers
- Being tested
- Blood-stage infection of P.vivax
- Keywords
- Advanced cancer, Plasmodium immunotherapy, Plasmodiun vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood-stage infection of P.vivaxBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Blood-stage infection of P.vivax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (8)
Progression free survival
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
Overall survival
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.
Measured: 2 years
Objective response rate (ORR)
The proportion of patients whose tumor is reduced to a certain amount and maintain a certain period of time.
Measured: 2 years
the Score of Quality of life
Patients are regularly filled with QLQ-C30 (cancer patient quality of life scale) to assess the quality of life of the patients.
Measured: 2 years
1 year of survival rate
The number of cancer cases remaining after 1 year of treatment / the total number of cancer cases treated * 100%.
Measured: 2 years
2 year of survival rate
The number of cancer cases remaining after 2 years of treatment / the total number of cancer cases treated * 100%.
Measured: 2 years
Immunological index
Detection of absolute number of immune cells（such as CD3+CD4+、CD3+CD8+ and so on ）in peripheral blood by flow cytometry.
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 posted18 Dec 2017
- Study start23 Nov 2017
- Primary completion31 Mar 2023
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Advanced CancersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CAS Lamvac Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375983
- Sponsor's protocol ID
- ZKLH-003
- Status last verified
- Feb 2024
- First submitted
- 10 Dec 2017
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21931708Qin 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.
PubMed 28228842Yang 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.
PubMed 28650446Liu 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.
PubMed 28445973
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Plasmodium Immunotherapy for Advanced Cancers
- ClinicalTrials.gov ID
- NCT03375983
- Acronym / sponsor ID
- ZKLH-003
- Conditions
- Advanced Cancers
- Keywords
- Advanced cancer, Plasmodium immunotherapy, Plasmodiun vivax
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- CAS Lamvac Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 18 Dec 2017 (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 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.
Detailed description
This study is to enroll 20 patients. Each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1.0 × 10^7 Plasmodium parasites and be observed for the exact infection time, parasitemia condition and infection course; principal clinical symptoms such as fever; gastrointestinal reaction; peripheral blood parameters;heart, liver and kidney function; changes in lung function, and dynamic changes in the function of peripheral immune cells. Moreover, the tolerance of patients to Plasmodium infection and changes in tumor-related parameters will be observed preliminarily.The duration of the planned treatment of each subject is 3-6 months. Since the successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples, the time of the treatment course is based on the presence of peripheral parasitemia. After 3-6 months, parasitemia will be terminated by antimalarial drugs for terminating the treatment of Plasmodium immunotherapy ( the immunological treatment effect may persist after the termination of Plasmodium infection).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood-stage infection of P.vivax | Experimental | Biological: Blood-stage infection of P.vivaxThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18-70 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);
- All the patients who have not received surgery, radiotherapy, chemotherapy or targeted drug therapy and refuse to accept the above treatments must meet all the remaining requirements that listed in the inclusion criteria;
- ECGO score of 0 or 1;
Key exclusion criteria (12 listed)
- 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;
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 |
|---|---|---|
| Blood-stage infection of P.vivaxThe 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. | Biological | Blood-stage infection of P.vivax |
Primary outcome
Number of participants with treatment-related adverse events as assessed by NCI CTCAE 4.0
Time frame: 2 years
Adverse events will be evaluated according to NCI CTCAE 4.0, and the incidence of adverse events will be calculated.
8 secondary outcomes
Progression free survival
Time frame: 2 years
Overall survival
Time frame: 2 years
Tumor marker level
Time frame: 2 years
Objective response rate (ORR)
Time frame: 2 years
the Score of Quality of life
Time frame: 2 years
1 year of survival rate
Time frame: 2 years
2 year of survival rate
Time frame: 2 years
Immunological index
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Results publication: PubMed 21931708Chen 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.
- Results publication: PubMed 28228842Qin 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.
- Results publication: PubMed 28650446Yang 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.
- Results publication: PubMed 28445973Liu 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Cancers
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
Non-small Cell Lung Cancer
RecruitingPhase 1/2
Efficacy and Safety of Ivonescimab Plus Pemetrexed and Platinum-Based Chemotherapy in Advanced Malignant Pleural Mesothelioma
Malignant Pleural Mesothelioma, Advanced
Active, not recruitingPhase 3
Testing the Timing of Pembrolizumab Alone or With Chemotherapy as First Line Treatment and Maintenance in Non-small Cell Lung Cancer
Lung Non-Squamous Non-Small Cell Carcinoma, Stage IIIB Lung Cancer AJCC v8
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Blood-stage infection of P.vivax in people with Advanced Cancers, run by CAS Lamvac Biotech 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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 20 Feb 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Qin, M.D (0086-18802043960, njlf@cas-lamvac.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by NCI CTCAE 4.0 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03375983, which also lists 4 linked publications.
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 20 Feb 2024.