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
Qualifiers
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
Treatments tested in this trial
- KSD-101
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov