A Study of TQ05105 in Patients With Chronic Graft Versus Host Disease

Phase 2Active Not RecruitingNCT04944043

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.45 enrolled

Overview

This study was a single arm, open label, multicenter phase Ib / II trial in subjects with glucocorticoid refractory / dependent moderate to severe cGVHD.The trial consisted of two phases: phase I for the dose exploration and phase II for the extension study.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Graft Versus Host Disease

Interventions

TQ05105 TabletDRUG

TQ05105 tablet is a Janus Kinase (JAK) inhibitor, which can inhibit the abnormal activation of JAK 2-V617F mutation, thereby inhibiting the sustained abnormal activation of JAK / STAT pathway.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Understood and signed an informed consent form. * ≥18 years old, Karnofsky Performance Scale of ≥60, life expectancy ≥ 6 months. * Has received allogeneic hematopoietic stem cell transplantation (alloSCT). * Clinically diagnosed moderate to severe cGVHD according to NIH Consensus Criteria. * Has received systemic or topical corticosteroids therapy and confirmed steroid-refractory/dependent cGVHD according to NIH Consensus Criteria. * Has received at least 1 lines of therapy for cGVHD. * Adequate laboratory indicators. * No pregnant or breastfeeding women, and a negative pregnancy test. Exclusion Criteria: * Has active acute GVHD. * Has previously failed to respond to JAK inhibitors for GVHD, or who had used JAK inhibitors within 4 weeks before the first administration. * Has uncontrollable active infections or infections requiring systematic treatment within 7 days before the first administration. * Development of other basic diseases. * Has malignant tumors within 3 years. * Has multiple factors affecting oral medication. * Has substance abuse or a psychotic disorder. * Has severe and / or uncontrolled disease. * Allergic to drugs or its constituents. * Has participated in any other clinical trials within 4 weeks before first administration. * According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Locations (12)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Maximal Tolerable Dose (MTD)

If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD. (Patients in phase Ib)

Time frame: Baseline up to 4 weeks

Recommended phase II dose (RP2D)

Recommended dose for phase II (Patients in phase Ib)

Time frame: Baseline up to 4 weeks

Best Overall Response Rate (BOR)

Percentage of participants achieving complete response (CR) and partial response (PR). (Patients in phase II)

Time frame: Baseline up to 96 weeks

Secondary Outcomes

Overall Response Rate (ORR)

Percentage of participants achieving complete response (CR) and partial response (PR) during the study according to the cGVHD NIH Consensus Criteria.

Time frame: Baseline up to 52 weeks

Duration of Response (DOR)

DOR defined as time from earliest date of disease response to earliest date of disease progression.

Time frame: Baseline up to 96 weeks

Overall survival (OS)

OS defined as the time from randomization to the time of death from any cause.

Time frame: Baseline up to death event, up to 5 years.

Non-relapse mortality (NRM)

Defined as the date of first dose to the date of death from non hematologic disease recurrence / progression

Time frame: Baseline up to 96 weeks

Data from ClinicalTrials.gov

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