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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease

A Randomized, Open-label, Multicenter Phase II Clinical Trial of Rovadicitinib in the Treatment of Third-line and Subsequent Moderate to Severe Chronic Graft-versus-host Disease (cGVHD).

A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease (NCT06300320) is a Phase 2 interventional studying Chronic Graft Versus Host Disease, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Chronic Graft Versus Host Disease and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 52 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Chronic Graft Versus Host Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Voluntary and signed willing to sign a consent form, good compliance; - Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months. - Received allogeneic hematopoietic stem cell transplantation; - Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD) - Received systemic therapies for cGVHD; - Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening; - Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ;platelet count (PLT) ≥30×10 9 /L; blood count (hemoglobin) at least 80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function; - Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study Who Should NOT Join This Trial: - Currently present or occured other malignancies within 3 years prior to first administration; - Known or suspected active acute graft versus host disease (aGVHD); - Presence of infection requiring treatment within 7 days prior to randomization; - Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants; - Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization; - Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc; - Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder; - Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment; - Have any severe or uncontrolled serious illness, including but not limited to,uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Voluntary and signed informed consent, good compliance; * Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months. * Received allogeneic hematopoietic stem cell transplantation; * Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD) * Received systemic therapies for cGVHD; * Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening; * Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ;platelet count (PLT) ≥30×10 9 /L; Hemoglobin ≥80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function; * Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study Exclusion Criteria: * Currently present or occured other malignancies within 3 years prior to first administration; * Known or suspected active acute graft versus host disease (aGVHD); * Presence of infection requiring treatment within 7 days prior to randomization; * Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants; * Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization; * Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc; * Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder; * Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment; * Have any severe or uncontrolled serious illness, including but not limited to,uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment; * Those who are allergic to the study drug or its components; * Participation in other clinical trials or major surgery within 4 weeks prior to the first dose; * Subjects judged by the investigator to be unsuitable for enrollment;

Treatments Being Tested

DRUG

TQ05105 tablets

Rovadicitinib (TQ05105) is a novel, oral dual JAK 1/2 and Rho-associated kinases (ROCK) 1/2 inhibitor targeting inflammatory and fibrotic components of cGVHD.

Locations (12)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Anhui Provincial Hospital
Hefei, Anhui, China
The 940th hospital of joint logistics support force of Chinese people's liberation army
Lanzhou, Gansu, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
Tai'an Central Hospital
Taian, Shangdong, China
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, China
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06300320), the sponsor (Chia Tai Tianqing Pharmaceutical Group Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06300320 clinical trial studying?

This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06300320?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06300320?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06300320. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06300320. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.