Not provided
Not provided
Not provided
Not provided
Not provided
No Participants Enrolled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The main purpose of this study is to determine the tolerability and feasibility of KSD-101 in patients with EBV-associated haematologic neoplasms,to observe the characteristics of dose-limiting toxicity (DLT)and to explore the range of effective dose.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSD-101 | Experimental | Biological: Dendritic Cell Vaccine( (Autologous monocyte-derived DCs pulsed withEBV-associated antigen) Patients will receive approximately (2.5-10)x10^6 DC vaccine via subcutaneous injections bi-weekly,totally 3-5 times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous monocyte-derived DCs pulsed withEBV-associated antigen | Biological | Patients will receive approximately (2.5-10)x10^6 DC vaccine via subcutaneous injections bi-weekly,totally 3-5 times. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicity(DLT) by dose group | Dose-limiting toxicity will be assessed after injection | 1 years after DC Vaccines injection |
| Incidence of Effective dose range by dose grouphaematologic neoplasms | Effective dose will be assessed after injection | 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 events(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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yang Jianmin | Changhai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Changhai Hospital | Shanghai | China | 430000 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |