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Trial Title:
Clinical Study of Therapeutic Immunological Agent for EBV-positive Advanced Malignant Tumors
NCT ID:
NCT05707910
Condition:
Malignant Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
EBV
tumor
immunotherapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
EBV immunological agent
Description:
Low-dose group:2*10^7 Medium-dose group:5*10^7 High-dose group:2*10^8
Arm group label:
Treatment Cohort
Other name:
Toripalimab 240mg
Summary:
To evaluate the safety of therapeutic immunological agent against EBV-positive advanced
malignancies, examining the incidence, type of occurrence, and severity of adverse events
in relation to the agent tested, and initially exploring the effectiveness of the
immunological agent.
Detailed description:
EBV (Epstein-Barr virus) is the first tumor-associated virus to be discovered, closely
related to a variety of malignant tumors, including nasopharyngeal carcinoma (NPC), a
variety of lymphomas, such as Hodgkin lymphoma (HL), non-Hodgkin lymphoma (NHL),
Burkitt's lymphoma (BL) and partial EBV positive stomach cancer (EBV-associated Gastric
Carcinomas, EBVaGC). Treatment of the above EBV+ tumors, surgery, radiotherapy and
chemotherapy are still the main methods, immunotherapy for some patients has shown good
efficacy, prolonging the patient's overall survival rate (Overall Survival, OS) and
progression-free survival rate (Progression-Free-Survival, PFS), but the overall clinical
efficacy needs to be further improved, and new treatment methods are urgently needed.
After tumor cells are infected with EBV virus, they will express a variety of EBV virus
antigens, which these proteins can promote the transformation and proliferation of human
cells, inhibit cell apoptosis and participate in the occurrence and development of
tumors, which also become candidate targets for research of immunotherapy because of the
strong antigenicity of viral antigens.
Therapeutic immunological agent was prepared which are naturally loaded with EBV antigens
and present them to activate T cells and dendritic cells(DC) in vitro and significantly
inhibit tumor growth in vivo. The agent also showed good safety. According to these
findings suggest the therapeutic immunological agent provides a new idea for
immunotherapy of EBV-related tumors.
The findings suggest that a number of patients with malignant tumors who failed EBV+
multi-line therapy, including nasopharyngeal cancer, NK/T lymphoma, and gastric cancer
needed to be treated with new immunotherapy method to achieve better outcomes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female patients: ≥ 18 years old; ≤ 70 years old;
2. Patients with EBV-positive advanced malignant tumors after failure of second-line
standard therapy (including PD-1 inhibitor therapy);
3. ECOG physical fitness score: 0~1 points;
4. Estimated survival ≥ 3 months;
5. The main organs have good function, that is, the relevant examination indicators
within random 14 days meet the following requirements:
1. Blood routine examination: hemoglobin ≥ 80 g/L (no blood transfusion within 14
days); Neutrophil count> 1.5×109/L; Platelet count≥ 80×109/L;
2. Biochemical examination: total bilirubin ≤ 1.5× ULN (upper limit of normal);
alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN;
If liver metastases are present, ALT or AST ≤ 5×ULN; Endogenous creatinine
clearance ≥ 60 ml/min (Cockcroft-Gault formula);
3. Cardiac Doppler ultrasound assessment: left ventricular ejection fraction
(LVEF)
- 50%.
6. Sign the informed consent form;
7. Good compliance, family members agree to cooperate with survival follow-up.
Exclusion Criteria:
1. Participated in clinical trials of other drugs within 4 weeks;
2. The patient has a history of other tumors, unless it is cervical cancer in situ,
treated cutaneous squamous cell carcinoma or bladder epithelial tumor or other
malignant tumor that has received radical treatment (at least 5 years before
enrollment)
3. Patients with uncontrolled cardiac clinical symptoms or diseases, such asheart
failure above NYHA grade 2, unstable angina, myocardial infarction within 1 year,
and clinically significant supraventricular or ventricular arrhythmias requiring
treatment or intervention.
4. For female subjects: pregnant or lactating women.
5. The patient has active tuberculosis, bacterial or fungal infection (≥ grade 2 of
NCI-CTC, 3rd edition); There is HIV infection with active HBV infection, HCV
infection.
6. Those who have a history of psychotropic drug abuse and have mental disorders who
cannot be remitted;
7. The subject has any active autoimmune disease or has a history of autoimmune disease
(such as, but not limited to uveitis, enteritis, pituitary inflammation, nephritis,
hyperthyroidism, hypothyroidism,Participants with vitiligo or who had complete
remission of asthma in childhood and did not require any intervention in adulthood
could be included; Participants in asthma requiring medical intervention with
bronchodilators were not included).
8. According to the judgment of the investigator, there are concomitant diseases that
seriously endanger the safety of patients or affect the completion of the patient's
research.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital
Address:
City:
Chendu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Xingchen Peng
Phone:
+86 18980606753
Email:
pxx2014@scu.edu.cn
Start date:
February 10, 2023
Completion date:
January 1, 2025
Lead sponsor:
Agency:
West China Hospital
Agency class:
Other
Source:
West China Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05707910
