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ENROLLING_BY_INVITATIONPHASE2

A Phase II Study Evaluating the Efficacy and Safety of ABSK021 (Pimicotinib)) in the Treatment of cGvHD Chronic Graft Versus Host Disease (cGvHD)

A Multicenter, Single-arm, Open-label, Phase II Clinical Study. This Study Consisting of Part A and Part B to Evaluate the Efficacy and Safety of ABSK021 (Pimicotinib) in Patients With Chronic Graft Versus Host Disease

NCT06186804•Abbisko Therapeutics Co, Ltd

View on ClinicalTrials.gov

Summary

This is a multicenter, single arm, open label phase II clinical study in China. This study will evaluate the efficacy and safety of ABSK021 (Pimicotinib) in the treatment of patients with cGvHD who failed first-line therapy.

Detailed Description

This is a phase II, open-label study to evaluate safety, tolerability, pharmacokinetics (PK), and clinical benefit of ABSK021 in patients with hormone refractory or relapsed cGvHD. This study consisted of Part A and Part B, all cGvHD patients in this study will receive continuous oral treatment with ABSK021 once a day (QD) in a 28-day cycle, complete the core treatment period and extended treatment period, and receive regular follow-up until the termination of treatment is determined.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Sign the informed consent and agree to comply with the requirements and restrictions set out in the informed consent.
•2. At the time of signing the informed consent., the patient must be at least 18 years old, regardless of gender ；
•3. Allogeneic hematopoietic stem cell transplantation from any donor source using bone marrow, peripheral blood stem cells, or cord blood.
•4. Patients who have received at least 1 line of systemic therapy
•5. If the patient is being treated with glucocorticoids or calcineurin inhibitor(CNI), the patient should have received a stable dose of the above treatment for not less than 2 weeks prior to the first use of ABSK021.
•6. ECOG (Eastern Cooperative Oncology Group Performance Status) physical strength score 0-2;7. The patient had sufficient organ and bone marrow function within 14 days prior to the first use of ABSK021.
•8\. For patients with Part A only: antifungal drugs that are currently being used in combination with CYP3A4 potent inhibitors should have been continuously used in accordance with regulations for no less than one week before the first use of ABSK021

Exclusion Criteria

•1. In previous treatment, he received highly selective colony stimulating factor 1 receptor (CSF-1R) targeted therapy, including small molecule or large molecule drugs;
•2. A known history of allergy to components of the investigational drug composition ;
•3. Patients continued to use CYP3A4 in combination with antifungal agents or in the two weeks prior to the initial administration of ABSK021 Strong inducer;
•4. The patient has received more than 5 lines of systemic therapy for cGvHD;
•5. The patient presented with aGvHD symptoms without cGvHD symptoms ;
•6. Any evidence of potential tumor or recurrence of post-transplant lymphoproliferative disease at the screening stage .
•7. There are factors that have been determined by the investigators to have a significant influence on oral drug absorption
•8. Present with cholestatic disease, or unresolved hepatic sinus obstruction syndrome/venous obstructive disease;
•9. active infection.
•10. During the screening period, the investigators judged that the patients had insufficient pulmonary function reserve, with FEV1≤ 39% or pulmonary function classification score of 3;
+3 more criteria

Locations (14)

Peking University People's Hospital

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of the Army Medical University

Chongqing, Chongqing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Guangdong Provincial Peoplep's Hospital

Guangzhou, Guangdong, China

ZhuJiang Hospital of Southern Medical University

Zhujiang, Guangdong, China

Tongji Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Union Hospital, Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

The Fir St Affiliated Hospital,Zhejiang Univer Sity School of Medicine

Hangzhou, Jiangsu, China

The First affiliated hospital of SuZhou University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Key Dates

Start Date

May 30, 2023

Primary Completion Date

October 30, 2026

Completion Date

December 30, 2026

Last Updated

August 12, 2024

Enrollment

ESTIMATED participants

Conditions

cGvHD

Interventions

ABSK021

DRUG

Ruxolitinib vs Prednisone as First-line Therapy for cGVHD Needing Systemic Therapy

NCT06660355

Chronic Graft-versus-host Disease (cGVHD)

View study

RECRUITINGEARLY_PHASE1

A Clinical Study Evaluating the Safety and Efficacy of GT729 Universal Cell Injection in the Treatment of Refractory or Relapsed Chronic Graft-versus-host Disease (cGVHD)

NCT07253259

cGVHD

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NOT_YET_RECRUITINGPHASE1/PHASE2

Gecacitinib in the Treatment of Steroid-Refractory/Dependent Chronic Graf Versus Host Disease (cGVHD).

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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