NCT05635591

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

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2023-01-16
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2022-12-02
• Last updated: 2026-04-08

Locations

1 site across 1 country: China