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NCT Number: NCT04944043

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital of USTC (Anhui Provincial Hospital), Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Maximal Tolerable Dose (MTD)

    Time frame: Baseline up to 4 weeks

    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)

  2. Recommended phase II dose (RP2D)

    Time frame: Baseline up to 4 weeks

    Recommended dose for phase II (Patients in phase Ib)

  3. Best Overall Response Rate (BOR)

    Time frame: Baseline up to 96 weeks

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

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Baseline up to 52 weeks

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

  2. Duration of Response (DOR)

    Time frame: Baseline up to 96 weeks

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

  3. Overall survival (OS)

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

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

  4. Non-relapse mortality (NRM)

    Time frame: Baseline up to 96 weeks

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

  5. Failure Free Survival (FFS)

    Time frame: Baseline up to 12 months

    Defined as absence of relapse, death, or need for additional systemic immunosuppressant cGVHD therapy.

  6. Changes in glucocorticoid dose

    Time frame: Baseline up to 96 weeks

    The reduction in glucocorticoid requirement would be regarded as an effect of the trial drug.

  7. Changes in symptom burden

    Time frame: Baseline up to 96 weeks

    Evaluate changes in symptom burden as measured by the Lee Symptom Scale. A change of 7 points on the Lee Symptom Scale will be considered clinically significant and relates to improvement in quality of life.

  8. Maximum plasma concentration (Cmax)

    Time frame: Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 1; Pre-dose of day 3,day5, day 6 ;Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 7.

    Cmax is the maximum plasma concentration of TQ05105 or its metabolite(s).

  9. Time to reach maximum plasma concentration (Tmax)

    Time frame: Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 1; Pre-dose of day 3,day5, day 6 ;Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 7.

    To characterize the pharmacokinetics of TQ05105 by assessment of time to reach maximum plasma concentration.

  10. Area under the plasma concentration time curve (AUC0-t)

    Time frame: Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 1; Pre-dose of day 3,day5, day 6 ;Pre-dose, 5, 15 , 30 minutes, 1 , 2 , 3 , 6, 8, 11 hours post-dose of day 7.

    To characterize the pharmacokinetics of TQ05105 by assessment of area under the plasma concentration time curve from zero to infinity.

  11. Incidence rate of adverse event

    Time frame: Baseline up to 96 weeks.

    The occurrence rate of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs) assessed based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Single Group, Open-Label, Multicenter ,Phase Ib/II Clinical Trials of TQ05105 Tablet in Patients With Glucocorticoid Refractory and Dependent Moderate to Severe Chronic Graft Versus Host Disease (cGVHD).

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Jun 29, 2021
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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