Adebrelimab Combined With Trametinib in the Treatment of Refractory Recurrent Langerhans Cell His… (NCT06902792) | Clinical Trial Compass
By InvitationPhase 1
Adebrelimab Combined With Trametinib in the Treatment of Refractory Recurrent Langerhans Cell Histiocytosis in Children and Adolescents
China6 participantsStarted 2025-02-06
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Diagnosis and Grouping Criteria for LCH: Pathological confirmation of LCH via lesion biopsy, with positive immunohistochemistry for CD1a and/or CD207 (Langerin). Diagnostic and grouping criteria adhere to the 2009 standards established by the International Organization Cell Association and the CCHG-LCH-2019 research protocol by the Chinese Children's Histiocyte Group (CCHG). Disease assessment and treatment efficacy are evaluated based on the criteria set by the Society of Tissue and Cell Biology and the CCHG-LCH-2019 protocol. Treatment efficacy is categorized as: (1) No Active Disease (NAD); (2) Active Disease Better (AD-B); (3) Active Disease Stable (AD-S); (4) Active Disease Intermedia (AD-I); (5) Active Disease Worse (AD-W); (6) Relapse: Recurrence of new lesions after achieving NAD, AD-B, or AD-S, following maintenance treatment for over 3 months; (7) Refractory Disease: For SS-LCH patients, if the evaluation after first-line treatment results in AD-I or AD-W, and second-line treatment with cladribine or clofarabine still yields AD-I or AD-W; or MS-LCH patients with AD-I or AD-W after first-line treatment.
. Refractory or Recurrent LCH Criteria: Cases must meet at least one of the criteria for refractory or recurrent LCH.
. Age Criteria: Initially, patients aged 6-17 years were included; subsequently, the age range was expanded to 1-17 years.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Disease Activity Score
Timeframe: Before the 1st, 2nd, 3rd, 4th, 5th, and 6th cycles(each treatment cycle consists of four weeks), 1 week after discontinuation, 3 months, 6 months, 1 year, 2 years, 3 years
Trial details
NCT IDNCT06902792
SponsorSecond Affiliated Hospital of Wenzhou Medical University
. Known hypersensitivity to the active ingredients or excipients of trametinib and/or Adebrelimab.
. History of autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, or Hashimoto's thyroiditis.
. History of or current active tuberculosis infection.
. Active infections requiring systemic treatment.
. Severe comorbid conditions, including but not limited to uncontrolled diabetes or active peptic ulcer disease.