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 range18 Years
SexALL
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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.
✓. Informed Consent: All patients or their legal guardians must provide signed informed consent.
✓. Performance Status: ECOG Performance Status (PS) score of 0-1; alternatively, a Karnofsky/Lansky Performance Status Scale score ≥ 50%.
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.