Suspended
KSD-101 Therapy for EBV-associated Lymphomas: an Exploratory Clinical Trial
What is being tested
Autologous monocyte-derived DCs pulsed withEBV-associated antigen
Biological
Who is being recruted
From 18 to 70 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Early Phase 1
Interventional
Study Start: June 2023
Summary
Principal SponsorKousai Bio Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 10, 2023
Actual date on which the first participant was enrolled.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.
Official TitleKSD-101 Therapy for EBV-associated Lymphomas: an Exploratory Clinical Trial
Principal SponsorKousai Bio Co., Ltd.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
7 inclusion criteria required to participate
The patient or his legal guardian participated voluntarily and signed the informed consent form.
A patient aged 18 - 70 years ( inclusive ) on the day of signing the informed consent form, male or female.
A patient who is diagnosed with EBV-associated Lymphomas，and fail to respond or relapse after conventional treatment, or voluntarily choose therapeutic DC vaccines as the salvage therapy.
ECOG performance score 0 - 1.
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12 exclusion criteria prevent from participating
A patient who has received any anticancer therapy such as chemotherapy, radiotherapy or immunotherapy (eg, immunosuppressive drugs) within one month prior to screening.
A female patient who is pregnant (positive urine/blood pregnancy test) or breastfeeding, or a male/female patient who plans to conceive in recent 1 year.
A patient who has positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb), with positive titer of hepatitis B virus (HBV) DNA in peripheral blood; or has positive hepatitis C virus (HCV) antibody, hepatitis C virus (HCV) RNA in peripheral blood, human immunodeficiency virus (HIV) antibody, or syphilis.
A patient who has central nervous system disorders (e.g., brain oedema, hormonal intervention indicated, or progression of brain metastases).
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalBiological: 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.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
SuspendedOne Study Center