Suspended
A Single-arm, Open Label, Multicenter Phase II Clinical Study in Rare Diseases to Evaluate Safety, Efficacy and PK of HLX208 for Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation
What is being tested
HLX208
Drug
Who is being recruted
Hemic and Lymphatic Diseases+6
+ Histiocytosis, Langerhans-Cell
+ Lung Diseases
Over 18 Years
+10 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: December 2021
Summary
Principal SponsorShanghai Henlius Biotech
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: December 6, 2021
Actual date on which the first participant was enrolled.The purpose of this study was to assess safety, efficacy and PK in adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) given HLX208 (BRAF V600E inhibitor).
Official TitleA Single-arm, Open Label, Multicenter Phase II Clinical Study in Rare Diseases to Evaluate Safety, Efficacy and PK of HLX208 for Adult Langerhans Cell Histiocytosis (LCH) and Erdheim-Chester Disease (ECD) With BRAF V600E Mutation
Principal SponsorShanghai Henlius Biotech
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Hemic and Lymphatic DiseasesHistiocytosis, Langerhans-CellLung DiseasesLymphatic DiseasesRespiratory Tract DiseasesHistiocytosisHistiocytosis, Non-Langerhans-CellLung Diseases, InterstitialErdheim-Chester Disease
Criteria
6 inclusion criteria required to participate
Aged ≥ 18 years;
Volunteer to participate in the clinical study;
Confirmed adult patients with LCH and/or ECD with BRAF V600E mutation;
At least one measurable lesion as per PERCIST v1.0;
Show More Criteria
4 exclusion criteria prevent from participating
Previous treatment with BRAF inhibitors or MEK inhibitors;
A history of other malignancies within two years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, adenocarcinoma in situ of the lung, or tumors that do not require interventional treatment after radical surgery;
Severe active infections requiring systemic anti-infective therapy;
Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalParticipants receive HLX208 450mg bid po
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
Peking Union Medical College Hospital
Beijing, ChinaOpen Peking Union Medical College Hospital in Google MapsSuspendedOne Study Center