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

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ClinicalTrials.gov Identifier: NCT04944043
Recruitment Status : Active, not recruiting
First Posted : June 29, 2021
Last Update Posted : July 27, 2023
Sponsor:
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Graft Versus Host Disease Drug: TQ05105 Tablet Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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).
Actual Study Start Date : June 25, 2021
Actual Primary Completion Date : June 30, 2023
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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Arm Intervention/treatment
Experimental: TQ05105 Tablet
TQ05105 tablet 10mg given orally, twice daily in 28-cycle.
 Drug: TQ05105 Tablet
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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04944043


Locations
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China, Anhui
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China, 230001
China, Guangdong
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510515
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 511457
China, Guangxi
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
China, Hebei
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
China, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
China, Hubei
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China, 430022
Tongji Hospital Tongji Medical College of HUST
Wuhan, Hubei, China, 430030
China, Jiangsu
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
China, Tianjin
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin, China, 300020
China, Zhejiang
The First Affiliated Hospital, Zhejiang University School of Medicine
Hanzhou, Zhejiang, China, 310000
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
More Information
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
ClinicalTrials.gov Identifier: NCT04944043    
Other Study ID Numbers: TQ05105-Ib/II-02
First Posted: June 29, 2021    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchiolitis Obliterans Syndrome
Graft vs Host Disease
Immune System Diseases
Organizing Pneumonia
Bronchiolitis Obliterans
Bronchiolitis
 Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases