A Phase I Clinical Study of KSD-101 in Patients With Relapsed or Refractory EBV-associated Hemato… (NCT07532746) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Phase I Clinical Study of KSD-101 in Patients With Relapsed or Refractory EBV-associated Hematological Malignancies
China55 participantsStarted 2026-05-01
Plain-language summary
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.
Who can participate
Age range2 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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) .
✓. Eastern Cooperative Oncology Group (ECOG) score of 0-1.
✓. The EBV-associated lymphoma population must have at least one measurable lesion (lymph node lesion with a longest diameter \> 15 mm, or extranodal lesion with a longest diameter \> 10 mm).
✓. Eligible for leukapheresis and has no other contraindications for cell collection.
✓. Must have adequate organ function (have not received blood transfusion or hematopoietic stimulating factor therapy within 28 days):
Exclusion criteria
✕. Received chemotherapy or immunosuppressive therapy within 4 weeks prior to leukapheresis or radiotherapy within 2 weeks prior to leukapheresis.
✕
What they're measuring
1
DLT
Timeframe: The duration from the first dose to Day 28
2
adverse events (AEs)
Timeframe: 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)
. 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.
✕. Underwent therapeutic surgery within 4 weeks prior to enrollment, or plan to undergo major surgery during the study, except diagnostic, biopsy and drainage procedures.
✕. Presence of uncontrolled infectious disease within 4 weeks prior to enrollment, except EBV infection.
✕. Receiving systemic corticosteroid therapy prior to screening and require long-term systemic corticosteroids during the treatment period (except inhalation or topical application) as judged by the investigator, or received systemic corticosteroid therapy (except inhalation or topical application) within 72 hours prior to administration.
✕. Active central nervous system metastases/lesions (e.g., brain edema requiring hormone intervention or brain metastases).