Clinical Study of Therapeutic Immunological Agent for EBV-positive Advanced Malignant Tumors

NCT05707910 | Active Not Recruiting Phase 1

• 1 other identifier: 2022-1389
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Malignant Tumor

Keywords

EBV; tumor; immunotherapy

Outcome Measures

Primary Outcomes (4)

• Adverse events

  The primary endpoint was safety, with adverse events (AEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.

  up to 12 months

• Objective response rate

  ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)

  up to 12 months

• Progress-Free Survival

  PFS is defined as the time from the administration of the first dose to first disease

  up to 12 months

• Overall Survival

  OS is defined as the time from the administration of the first dose to death.

  up to 12 months

Study Arms (1)

Treatment Cohort

EXPERIMENTAL

EBV immunological agent administration on day 0,7,14,28 and 60 for subcutaneous injection.

Biological: EBV immunological agent

Interventions

EBV immunological agent BIOLOGICAL

2\*10\^7 and 5\*10\^7

Also known as: Toripalimab 240mg

Treatment Cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients: ≥ 18 years old; ≤ 70 years old;
• Patients with EBV-positive advanced malignant tumors after failure of second-line standard therapy (including PD-1 inhibitor therapy);
• ECOG physical fitness score: 0\~2 points;
• Estimated survival ≥ 3 months;
• The main organs have good function, that is, the relevant examination indicators within random 14 days meet the following requirements:
• Blood routine examination: hemoglobin ≥ 80 g/L (no blood transfusion within 14 days); Neutrophil count\> 1.5×10\^9/L; Platelet count≥ 80×10\^9/L;
• 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);
• Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ 50%.
• Sign the informed consent form;
• Good compliance, family members agree to cooperate with survival follow-up.

You may not qualify if:

• Participated in clinical trials of other drugs within 4 weeks;
• 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)
• 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.
• For female subjects: pregnant or lactating women.
• The patient has active tuberculosis, bacterial or fungal infection; There is HIV infection with active HBV infection, HCV infection.
• Those who have a history of psychotropic drug abuse and have mental disorders who cannot be remitted;
• 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).
• 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.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Related Publications (21)

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MeSH Terms

Conditions

Neoplasms

Interventions

toripalimab

Study Officials

• Xingchen Peng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: February 1, 2023
• Study Start: February 8, 2023
• Primary Completion: April 24, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)