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Adebrelimab Combined With Trametinib in the Treatment of Refractory Recurrent Langerhans Cell Histiocytosis in Children and Adolescents

NCT06902792 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-03-30

No results posted yet for this study

Summary

Phase 1, 1 case in total

Subject 1:

This study marks the first application of Adebrelimab in pediatric patients with Langerhans Cell Histiocytosis (LCH). The initial dose is 20 mg/kg, delivered via a 60-minute intravenous infusion. If no Dose-Limiting Toxicity (DLT) occurs, the second dose of 20 mg/kg will be administered in the second cycle. Treatment cycles consist of dosing every 4 weeks, up to a maximum of 6 cycles.

Phase 2, 2-5 cases in total

Subjects 2 and 3:

If the first subject exhibits no DLT, the second and third subjects will be enrolled and receive 20 mg/kg of Adebrelimab on day 1. Treatment cycles will last 4 weeks, with dosing administered every 4 weeks, for up to 6 cycles.

Subjects 4-6:

If one DLT occurs among the first three subjects, three additional subjects will be enrolled and given 20 mg/kg of Adebrelimab. If two or more DLTs occur among the first three subjects, three additional subjects will be enrolled and administered a reduced dose of 10 mg/kg.

Following the successful completion of these phases, a subsequent phase will commence to further assess the efficacy and safety of Adebrelimab and fulfill the biological research objectives.

Conditions

  • Histiocytosis, Langerhans-Cell

Interventions

DRUG

treated group

This study marks the first application of Adebrelimab in pediatric patients with Langerhans Cell Histiocytosis (LCH). The initial dose is 20 mg/kg, delivered via a 60-minute intravenous infusion. If no Dose-Limiting Toxicity (DLT) occurs, the second dose of 20 mg/kg will be administered in the second cycle. Treatment cycles consist of dosing every 4 weeks, up to a maximum of 6 cycles.

Sponsors & Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-06
Primary Completion
2025-08-06
Completion
2026-02-02

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 NCT06902792 on ClinicalTrials.gov