Antitumor effect of malaria parasite infection in a murine Lewis lung cancer model through induction of innate and adaptive immunity.
Lili Chen, Zhengxiang He, Li Qin...
https://pubmed.ncbi.nlm.nih.gov/21931708Actively Recruiting
Phase 1
Phase 2
Age: 18Years - 70Years
All Genders
ID03375983
Clinical Study of Plasmodium Immunotherapy for Advanced Cancers
Led by CAS Lamvac Biotech Co., Ltd. · Updated on 2024-02-20
20
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and preliminary effectiveness of Plasmodium immunotherapy for patients with advanced cancers. This study aims to observe how the treatment affects tumor-related parameters and patients' immune function. It is a combined Phase 1 and Phase 2 clinical trial enrolling 20 patients with solid tumors, excluding certain cancer types, to better understand responses to this novel immunotherapy. Each patient will receive a single vaccination of P. vivax-infected red blood cells containing approximately 0.3-1.0 x 10^7 Plasmodium parasites. The treatment period lasts between 3 to 6 months from the day when successful infection is confirmed by detecting parasites in the blood under a microscope. After this period, antimalarial drugs will be given to end the infection and treatment, although immune effects may continue beyond this point. Participants will be regularly monitored for infection timing, parasite levels, clinical symptoms such as fever and gastrointestinal reactions, and changes in blood and organ functions. Researchers will also track immune cell activity and tumor markers over the study period. The main outcome is the number of treatment-related adverse events over two years, with additional measures including survival rates, tumor response, quality of life, and immune system indexes. The total follow-up duration for these assessments is two years.
CONDITIONS
Brief Title
Plasmodium Immunotherapy for Advanced Cancers
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years, male or female.
- Confirmed advanced cancer by biopsy and imaging with clear measurable tumor lesions, including colon, breast, liver, lung, gastric cancer, sarcoma, and other solid tumors (excluding nasopharyngeal carcinoma, lymphatic cancer, cervical cancer, and melanoma).
- At least 3 months since last chemotherapy or radiotherapy, or 5 half-lives since last targeted drug therapy.
- Patients not receiving or refusing surgery, radiotherapy, chemotherapy, or targeted therapy must meet other criteria.
- ECOG performance status of 0 or 1.
- Expected survival of at least 6 months.
- Platelet count ≥100x10^9/L, neutrophil count ≥1.5x10^9/L, hemoglobin ≥100 g/L; no significant red blood cell abnormalities or anemia.
- Normal or near-normal immune cell counts and immune function; basic normal heart, lung, liver, and kidney function (Child-Pugh class A or B liver function, creatinine ≤1.5 times upper limit).
- Ability to comply with follow-up requirements.
- Able to understand and sign informed consent.
You will not qualify if you...
- Severe hemoglobin disease or severe G6PD deficiency.
- History of splenectomy or splenomegaly.
- Drug addiction or alcohol dependence.
- Newly diagnosed CNS metastasis or uncontrolled serious systemic diseases including active infection, severe hypertension, unstable angina, heart failure, severe arrhythmia, liver or kidney dysfunction, metabolic diseases, or neurological or psychiatric disorders.
- Receiving any other anti-tumor treatments during the study.
- Significantly reduced immune function compared to normal population.
- Severe lung impairment with MNW <39%, inability to get out of bed, or resting breathlessness.
- Severe cough, difficulty eating, or poor cooperation.
- Poor overall health that precludes tolerance of immunotherapy.
- Pregnant or breastfeeding women.
- Positive pregnancy test in women of childbearing age.
- Any other condition making participation unsuitable as judged by the investigator.
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 to 6 months
Participants are vaccinated with P. vivax-infected red blood cells and observed for infection and clinical symptoms. The treatment lasts 3 to 6 months from the day of successful infection and ends with antimalarial drugs to terminate parasitemia.
Regular visits during treatment for monitoring infection and symptoms
Trial Site Locations
Total: 1 location
1
Guangzhou Fuda Tumor Hospital
Guangzhou, Guangdong, China, 510000
Actively Recruiting
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Research Team
L
Li Qin, M.D
S
Suyi Zhang, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Worldwide malaria incidence and cancer mortality are inversely associated.
Li Qin, Changzhong Chen, Lili Chen...
https://pubmed.ncbi.nlm.nih.gov/28228842Exosomes from Plasmodium-infected hosts inhibit tumor angiogenesis in a murine Lewis lung cancer model.
Y Yang, Q Liu, J Lu...
https://pubmed.ncbi.nlm.nih.gov/28650446Plasmodium parasite as an effective hepatocellular carcinoma antigen glypican-3 delivery vector.
Quan Liu, Yijun Yang, Xuefang Tan...
https://pubmed.ncbi.nlm.nih.gov/28445973