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

NCT04944043 | Active Not Recruiting Phase 1

• 1 other identifier: TQ05105-Ib/II-02
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Chronic Graft Versus Host Disease

Outcome Measures

Primary Outcomes (3)

• 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)

  Baseline up to 4 weeks

• Recommended phase II dose (RP2D)

  Recommended dose for phase II (Patients in phase Ib)

  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)

  Baseline up to 96 weeks

Secondary Outcomes (11)

• Overall Response Rate (ORR)

  Baseline up to 52 weeks

• Duration of Response (DOR)

  Baseline up to 96 weeks

• Overall survival (OS)

  Baseline up to death event, up to 5 years.

• Non-relapse mortality (NRM)

  Baseline up to 96 weeks

• Failure Free Survival (FFS)

  Baseline up to 12 months

Study Arms (1)

TQ05105 Tablet

EXPERIMENTAL

TQ05105 tablet 10mg given orally, twice daily in 28-cycle.

Drug: TQ05105 Tablet

Interventions

TQ05105 Tablet DRUG

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.

TQ05105 Tablet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (12)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, 230001, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510280, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 511457, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, 530021, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, 430030, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, 300020, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hanzhou, Zhejiang, 310000, China

Location

Related Publications (1)

• Zhao YM, Luo Y, Shi JM, Wang SQ, Wang CK, Jiang EL, Liang C, Zhu XY, Zhang XJ, Meng FK, Jin H, Zhao YQ, Yu J, Lai XY, Liu LZ, Fu HR, Ye YS, Zhang CX, Wang T, Tu LF, Wang XQ, Huang H. A first-in-class JAK/ROCK inhibitor, rovadicitinib, for glucocorticoid-refractory or -dependent chronic GVHD. Blood. 2025 Jun 12;145(24):2857-2872. doi: 10.1182/blood.2024026581.

  PMID: 40009501 DERIVED

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: June 25, 2021
• Primary Completion: June 30, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Locations

CN (12)