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| Name | Class |
|---|---|
| Kousai Bio Co., Ltd. | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSD-101 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous monocyte - derived DCs pulsed with EBV antigen | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) by dose group | Dose limiting toxicity will be assessed after injection in each dose group | 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 | 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. | 1 years after DC Vaccines injection |
| Measure | Description | Time Frame |
|---|---|---|
| EBV-DNA load | The load levels of EBV-DNA will be detected at each time point | 1 years after DC Vaccines injection |
| Objective response rate (ORR) | The percentage of participants who achieved PR or better response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Chunrui | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Li Chunrui | Wuhan | Hubei | 430000 | China |
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| 1 years after DC Vaccines injection |
| Disease control rate (DCR) | The percentage of participants who achieved SD or better response | 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 | 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 | 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 | 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 | 1 years after DC Vaccines injection |
| Levels of B cells | B cells in peripheral blood will be assessed to monitor changes | 1 years after DC Vaccines injection |
| Levels of NK cells | NK cells in peripheral blood will be assessed to monitor changes | 1 years after DC Vaccines injection |