A Phase 1 interventional study of EBV immunological agent in CAEBV (Chronic Active Epstein-Barr Virus Infection) Syndrome and PTLDs, sponsored by West China Hospital. Not yet recruiting at 1 site in China. Open to participants aged 2 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-10-30.
Sponsored by West China Hospital · Phase 1, Interventional, and Treatment
This study intends to conduct a prospective single-center open single-arm multi-dose escalation study on therapeutic immunological agent treatment in patients with Lymphoproliferative disease associated with EBV to observe the safety and efficacy.
9,173 studies on the registry are indexed under Syndrome; 1,007 are open to participants now.
This study's planned enrollment of 27 is below the median of 50 across 6,480 interventional studies indexed under Syndrome.
Browse Syndrome studies →West China Hospital is the lead sponsor of 497 studies on the registry; 243 are open to participants now.
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For CAEBV patients and others with EBV-LPD 1). Patients who have signed informed consent before the trial and have a full understanding of the trial content, process and possible adverse reactions, and can complete the study according to the requirements of the trial protocol; 2). Patients with evidence consistent with the following diagnoses:
a. Patients with the 2016 version of WHO's CAEBV diagnostic criteria (except
B-lymphocyte involvement only) :
Persistent or recurrent infectious IM-like symptoms lasting for more than 3 months;
Increased EBV-DNA load in peripheral blood or tissue lesions: the level of EBV-DNA in peripheral blood was higher than 10\^2.5 copies/μg DNA; ③ EBV-infected T cells or NK cells were found in the affected tissues or peripheral blood;
④ Exclude other possible diagnoses, such as primary EBV infection (IM), autoimmune diseases, neoplastic diseases, other viral infections (HBV, HIV, HCV, etc.), and congenital or secondary immunodeficiency diseases; Or b. EBV-PLD patients with evidence consistent with pathological diagnosis of EBV antigen positive; 3). Male and female, 2-70 years old (including the critical value); 4). Patients with EBV-DNA≥1000 copies/mL or EBER+; 5). Before the study, total bilirubin ≤ 2 times of the upper limit of normal value, blood creatinine ≤ 1.5 times of normal value; Fibrinogen can be corrected to ≥0.6g/L after infusion.
6). Before the study, hemoglobin ≥60g/L, platelets ≥50×10\^9/L, neutrophil count ≥1×10\^9/L; 7). Echocardiography showed LVEF ≥ 50%; 8). Women of childbearing age must confirm through a pregnancy test that they are not pregnant and be willing to use effective contraception during the test period and for ≥12 months after the last dose; 9). The compliance was good, and the patients and their families were willing to cooperate with the later follow-up.
Exclusion Criteria:
Patients were excluded if they met any of the following criteria:
EBV immunological agent administration on day 0,7,14,21 and 42 for Intradermal or Subcutaneous Injection
Biological: EBV immunological agent
27 participants with will be enrolled in the study and divided into three groups, including EBV-LPD (Adults group), EBV-LPD (Children group) and PTLD (Adults group） each with 9 people.The participants will be divided into three different dose groups, and a "3+3" dose escalation design is used. The low dose is 5.0×10\^5, the medium dose is 2.0×10\^6 and the high dose is 5.0×10\^6 for children and low dose is 5.0×10\^6, the medium dose is 2.0×10\^7 and the high dose is 5.0×10\^7 for adults. Only one dose will be administered to each participant with EBV immunological agent combined with Toripalimab 240mg.
Safety and tolerability
Number of participants who experience grade 1 or higher adverse events, as defined by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Time frame: up to 12 months
Quality of life for patients
The EORTC QLQ-C30 consists of five functional scales, nine symptom scales and one global quality of life (QoL) scale, and has been validated in an international setting
Time frame: up to 12 months
Effectiveness
The number of subjects with CR and PR, calculate the duration from the time of initial administration to the date of disease progression or the date of subject's death
Time frame: up to 12 months
Plan to share: No
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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