Clinical Trial

A Preliminary Clinical Study on the Efficacy of Cyclophosphamide and Sirolimus Combined With VIC-1911 in Preventing Graft-versus-Host Disease After Haploidentical Stem Cell Transplantation in Children

Study acronym: GVHD
Not Yet Recruiting Phase 1
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Summary
This study is a single arm, open label Phase Ib clinical trial, consisting of two parts: the first part is a safety introduction trial, and the second part is a dose escalation trial. In the first part, the tolerability, safety, PK characteristics, PD characteristics, and preliminary efficacy of VIC-1911 tablets in combination with PTCy and sirolimus will be explored. The first part will conduct safety introduction tests at the same dose as those already tested abroad to determine the dosage required for VIC-1911 tablets to meet safety and effective biological activity. The dose limiting toxicity (DLT) in Phase I study will be evaluated from the first administration of VIC-1911 tablets to 28 days after administration. On this basis, the second part of the experiment will be conducted to further explore the effectiveness and safety of VIC-1911 tablets combined with PTCy and sirolimus under RP2D for preventing GVHD in haplo HSCT patients after myeloablative pretreatment
Trial Details
NCT Number NCT07350057
Lead Sponsor Shanghai Jiao Tong University School of Medicine
Conditions GVHD (Acute or Chronic)
Enrollment 9 participants
Start Date 2026-03-25
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-12-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-20