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KSD-101 Therapy for EBV-associated Haematologic Neoplasms: an Exploratory Clinical Trial

NCT05635591 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-04-08

No results posted yet for this study

Summary

The primary objectives of this study is to evaluate the tolerability and safety of KSD-101 in Patients with EBV-associated haematologic neoplasms, observe the dose-limiting toxicity (DLT) and and to explore the maximum tolerated dose (MTD).

Conditions

  • EBV-associated Haematologic Neoplasms

Interventions

BIOLOGICAL

Autologous monocyte - derived DCs pulsed with EBV antigen

Patients will receive approximately （5-10）x10\^6 DC vaccine via subcutaneous injections bi-weekly,totally 3-5 times.Doses 4 and 5 are designated as booster doses. The need for booster treatment and the exploration of alternative immunization schedules shall be determined by the Investigator based on the subject's condition.For subjects in the dose expansion phase, concomitant therapy recommended by the Investigator is permitted if the subject has a high tumor burden. In the event of disease progression, the Investigator is allowed to select an appropriate treatment regimen based on the subject's condition, while the subject may choose to continue receiving treatment KSD-101. If the subject declines to continue treatment KSD-101 but agrees to survival follow-up, they will be transitioned to the survival follow-up phase.

Sponsors & Collaborators

  • Kousai Bio Co., Ltd.

    collaborator OTHER

  • Tongji Hospital

    lead OTHER

Principal Investigators

  • Li Chunrui · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-16
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05635591 on ClinicalTrials.gov