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Chronic Graft Versus Host DiseasePhase 1/2NCT04944043

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

A Phase 1/2 study testing TQ05105 Tablet in people with Chronic Graft Versus Host Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Graft Versus Host Disease
What is being tested?
TQ05105 Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
12 sitesChina
Study dates
25 Jun 2021to 31 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510280

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510515

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 511457

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hanzhou, Zhejiang, 310000

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei, Anhui, 230001

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

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

    Tianjin, Tianjin Municipality, 300020

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

    Wuhan, Hubei, 430022

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

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).

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.

Being tested
TQ05105 Tablet
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04944043
Study groupRoleWhat they receive
TQ05105 TabletExperimentalTQ05105 tablet 10mg given orally, twice daily in 28-cycle.
Receives: Drug: TQ05105 Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline up to 4 weeks

  2. Recommended phase II dose (RP2D)

    Recommended dose for phase II (Patients in phase Ib)

    Measured: Baseline up to 4 weeks

  3. Best Overall Response Rate (BOR)

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

    Measured: Baseline up to 96 weeks

Secondary outcomes (11)

  1. 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.

    Measured: Baseline up to 52 weeks

  2. Duration of Response (DOR)

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

    Measured: Baseline up to 96 weeks

  3. Overall survival (OS)

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

    Measured: Baseline up to death event, up to 5 years.

  4. Non-relapse mortality (NRM)

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

    Measured: Baseline up to 96 weeks

  5. Failure Free Survival (FFS)

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

    Measured: Baseline up to 12 months

  6. Changes in glucocorticoid dose

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

    Measured: Baseline up to 96 weeks

  7. Changes in symptom burden

    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.

    Measured: Baseline up to 96 weeks

  8. Maximum plasma concentration (Cmax)

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

    Measured: 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.

  9. Time to reach maximum plasma concentration (Tmax)

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

    Measured: 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.

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

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

    Measured: 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.

  11. Incidence rate of adverse event

    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.

    Measured: Baseline up to 96 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2021
  2. Study start25 Jun 2021
  3. Primary completion30 Jun 2023
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04944043
Sponsor's protocol ID
TQ05105-Ib/II-02
Status last verified
Dec 2025
First submitted
21 Jun 2021
Last updated
3 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40009501

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQ05105 Tablet in people with Chronic Graft Versus Host Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal Tolerable Dose (MTD) (time frame: Baseline up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04944043, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

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