The main purpse of this study is to evaluate the safety and tolerability of KSD-101 in the treatment of relapsed or refractory EBV-associated hematological malignancies,to preliminarily explore the clinical efficacy ,evaluate the immune response to KSD-101 for the treatment in Patients with EBV-associated hematological diseases and the improvement in subjects' quality of life (QOL) after KSD-101 treatment.
This is a multi-center, single-arm, open-label, dose confirmation and expansion Phase I clinical study to evaluate the safety, tolerability, immune response, and preliminary clinical efficacy of KSD-101 in the treatment of relapsed or refractory EBV-associated hematological malignancies. The study is divided into three stages by age.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Patients will receive DC vaccine via subcutaneous injections bi-weekly,total 3-5 times. KSD-101 treatment dose: The dose is tentatively set at 2.5 or 5.0 × 10\^6 cells/dose in the adult cohort.
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
DLT
Incidence and number of dose-limiting toxicities.
Time frame: The duration from the first dose to Day 28
adverse events (AEs)
Adverse events will be graded according to the NCI-CTCAE 6.0 grading criteria throughout the study period, except for injection site (localized) adverse events, which will be graded with reference to the Guiding Principles for Grading Adverse Events in Vaccine Clinical Trials (Revised Edition).
Time frame: Any adverse medical event occurring from the initiation of leukapheresis until 28 days (±7 days) after the last dose, or initiation of a new treatment (whichever occurs first)
EBV-DNA load
Antiviral effect: changes in EBV-DNA load were assessed during the study
Time frame: The duration from the first dose to 48 weeks
Objective response rate (ORR)
The percentage of participants who achieved PR or better response
Time frame: The duration from the first dose to 48 weeks
Overall survival (OS)
OS is measured from the date of the initial injection of DC Vaccines to the date of the participant's death
Time frame: The duration from the first dose to 48 weeks
Disease control rate (DCR)
The percentage of participants who achieved SD or better response
Time frame: The duration from the first dose to 48 weeks
Progression-free survival (PFS)
The time from the start of KSD-101 treatment for the participants to the first time of disease progression or death for any reason
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Time frame: The duration from the first dose to 48 weeks
Levels of EBV-specific CD8+ T cells
EBV-specific CD8+ T cells in peripheral blood will be assessed to monitor changes
Time frame: The duration from the first dose to 48 weeks
Levels of various lymphocyte subsets
total T lymphocytes, activated T lymphocytes, helper T lymphocytes, cytotoxic T lymphocytes, regulatory T lymphocytes, total B lymphocytes and total NK cells in peripheral blood will be assessed to monitor changes
Time frame: The duration from the first dose to 48 weeks
EQ-5D-5L
The change from baseline in scores of EQ-5D-5L endpoints will be analyzed by age group or indication group.
Time frame: The duration from the first dose to 48 weeks
QLQ-C30
The change from baseline in scores of QLQ-C30 endpoints will be analyzed by age group or indication group
Time frame: The duration from the first dose to 48 weeks