A Phase I Clinical Study of KSD-101 in Patients With Relapsed or Refractory EBV-associated Hematological Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-70
SponsorKousai Bio Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects and/or their legal guardians agree to participate and sign the ICF.
Male or female subjects who are 2-70 (inclusive,If the age exceeds 70 years, the decision will be made jointly by the investigator and the sponsor.) years old.
Subjects with histologically and/or cytologically confirmed EBV-associated hematological diseases, including but not limited to EBV-positive diffuse large B-cell lymphoma, EBV-positive NK/T-cell lymphoma, EBV-positive Hodgkin's lymphoma, EBV-positive Burkitt lymphoma, EBV-positive nodal T follicular helper (TFH) cell lymphoma (angioimmunoblastic-type), and EBV-positive primary cutaneous T-cell lymphoma, and meeting the following conditions
Positive for EBER by in situ hybridization (ISH or FISH) .
Disqualifiers
Received chemotherapy or immunosuppressive therapy within 4 weeks prior to leukapheresis or radiotherapy within 2 weeks prior to leukapheresis.
Underwent allogeneic transplantation prior to enrollment.
Received (attenuated) live vaccines within 4 weeks prior to enrollment.
Participated in other clinical studies within 4 weeks prior to enrollment and received at least one dose of the investigational product.
Trial design
Design model
Single group
Treatments tested in this trial
KSD-101
Biological/VaccinePatients 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.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: KSD-101Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
DLT
Incidence and number of dose-limiting toxicities.
Time frame
The duration from the first dose to Day 282
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)Secondary outcomes
1
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 weeks2
Objective response rate (ORR)
The percentage of participants who achieved PR or better response
Time frame
The duration from the first dose to 48 weeks3
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 weeks4
Disease control rate (DCR)
The percentage of participants who achieved SD or better response
Time frame
The duration from the first dose to 48 weeksSponsors and contacts
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Source ClinicalTrials.gov
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