Not Yet RecruitingPhase 1

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

9 participantsStarted 2026-03-25

Plain-language 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

Who can participate

Age range8 Years – 18 Years

SexALL

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Inclusion criteria

✓. Children aged 8-18, regardless of gender;
✓. Prior to the start of the study, the subjects and their legal guardians shall sign a written informed consent form;
✓. Patients diagnosed with the following blood diseases and deciding to undergo haplo HSCT:
✓. Patients diagnosed with acute myeloid leukemia or high-risk acute lymphoblastic leukemia who have achieved complete remission (CR) through induction therapy;;
✓. Patients diagnosed with myelodysplastic syndrome (MDS) and with an International Prognostic Scoring System (IPSS, please refer to Appendix 1a) score of medium risk 2 or high risk, or with severe blood cell reduction in the IPSS low-risk group, who have undergone ineffective treatment or have poor prognosis due to genetic abnormalities (such as -7,3q26 rearrangement, TP53 gene mutation, complex karyotype, monomeric karyotype);
✓. There are peripheral blood stem cell donors who are 5/10 HLA haploidentical;
✓. Karnofsky (KPS) score (see Appendix 2) ≥ 80 points;
✓. Possess sufficient organ functions, including:

Exclusion criteria

What they're measuring

1.Determine the recommended phase 2 dose (RP2D) of VIC-1911 tablets combined with post transplant cyclophosphamide (PTCy) and sirolimus for the prevention of GVHD in haplo HSCT pediatric patients (Only evaluated in Part 1)

Timeframe: Expected 2 years

Trial details

NCT IDNCT07350057

SponsorShanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-01

Contact for this trial

wang xiaodong, PI

189 3869 1232 donlevin@live.cn

View on ClinicalTrials.gov More GVHD (Acute or Chronic) trials