The primary objectives of this study is to evaluate the tolerability and safety of KSD-101 in Patients with EBV-associated haematologic neoplasms, observe the dose-limiting toxicity (DLT) and and to explore the maximum tolerated dose (MTD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Patients will receive approximately (5-10)x10\^6 DC vaccine via subcutaneous injections bi-weekly,totally 3-5 times.Doses 4 and 5 are designated as booster doses. The need for booster treatment and the exploration of alternative immunization schedules shall be determined by the Investigator based on the subject's condition.For subjects in the dose expansion phase, concomitant therapy recommended by the Investigator is permitted if the subject has a high tumor burden. In the event of disease progression, the Investigator is allowed to select an appropriate treatment regimen based on the subject's condition, while the subject may choose to continue receiving treatment KSD-101. If the subject declines to continue treatment KSD-101 but agrees to survival follow-up, they will be transitioned to the survival follow-up phase.
Li Chunrui
Wuhan, Hubei, China
Incidence of dose-limiting toxicity (DLT) by dose group
Dose limiting toxicity will be assessed after injection in each dose group
Time frame: 1 years after DC Vaccines injection
Incidence of maximally tolerated dose (MTD) by dose grouphaematologic neoplasms
Maximally tolerated dose will be assessed after injection in each dose group
Time frame: 1 years after DC Vaccines injection
Type and incidence of adverse events (AEs) and serious adverse events (SAEs) by dose group
Calculate type and incidence of adverse events (AE), serious adverse event (SAE), including those happened after injection, those related to study drug, or those that led to withdrawal from the study. They will also be aggregated by systematic organ classification (SOC), preferred term (PT), and severity.
Time frame: 1 years after DC Vaccines injection
EBV-DNA load
The load levels of EBV-DNA will be detected at each time point
Time frame: 1 years after DC Vaccines injection
Objective response rate (ORR)
The percentage of participants who achieved PR or better response
Time frame: 1 years after DC Vaccines injection
Disease control rate (DCR)
The percentage of participants who achieved SD or better response
Time frame: 1 years after DC Vaccines injection
Duration of response (DOR)
DOR will be calculated among responders (with a PR or better response) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease
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Time frame: 1 years after DC Vaccines injection
Progression-free survival (PFS)
The time from the start of CAR-GPRC5D treatment for the participants to the first time of disease progression or death for any reason
Time frame: 1 years after DC Vaccines injection
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: 1 years after DC Vaccines injection
Levels of EBV-specific CD8+ T cells
EBV-specific CD8+ T cells in peripheral blood will be assessed to monitor changes
Time frame: 1 years after DC Vaccines injection
Levels of B cells
B cells in peripheral blood will be assessed to monitor changes
Time frame: 1 years after DC Vaccines injection
Levels of NK cells
NK cells in peripheral blood will be assessed to monitor changes
Time frame: 1 years after DC Vaccines injection