Can a new pill tame the immune System's attack after stem cell transplants?
NCT ID NCT06300320
First seen Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time
Summary
This phase II trial is testing an oral medication called rovadicitinib in adults with moderate to severe chronic graft-versus-host disease (cGVHD), a condition where donor immune cells attack the recipient's body after a stem cell transplant. The drug aims to reduce both inflammation and fibrosis, which are key drivers of cGVHD. The study will measure how many patients achieve a meaningful response after 24 weeks of treatment, as well as the duration of that response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Rovadicitinib (TQ05105), an oral dual JAK 1/2 and ROCK 1/2 inhibitor
- What this could lead to
- If successful, this could offer a new oral treatment option for patients with chronic graft-versus-host disease who have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial with a small number of participants, so results may not be conclusive. The drug may cause side effects or may not improve outcomes for all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 65 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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;
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anhui Provincial Hospital
NOT_YET_RECRUITINGHefei, Anhui, 230001, China
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Guangzhou First People's Hospital
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510180, China
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Hematology Hospital of the Chinese Academy of Medical Sciences
NOT_YET_RECRUITINGTianjin, Tianjin Municipality, 300020, China
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Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
NOT_YET_RECRUITINGShanghai, Shanghai Municipality, 200025, China
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Tai'an Central Hospital
NOT_YET_RECRUITINGTaian, Shangdong, China
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The 940th hospital of joint logistics support force of Chinese people's liberation army
NOT_YET_RECRUITINGLanzhou, Gansu, 730050, China
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The Affiliated People's Hospital of Ningbo University
NOT_YET_RECRUITINGNingbo, Zhejiang, 315040, China
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The First Affiliated Hospital of Guangxi Medical University
NOT_YET_RECRUITINGNanning, Guangxi, 530021, China
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The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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The Second Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITINGXi'an, Shannxi, 710299, China
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The Second Hospital of Hebei Medical University
NOT_YET_RECRUITINGShijiazhuang, Hebei, 050000, China
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Xiangyang Central Hospital
NOT_YET_RECRUITINGXiangyang, Hubei, 441021, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new pill outperform standard care for a tough transplant complication?
- Can meditation tame the Long-Term side effects of a stem cell transplant?
- Could a liquid form of a Graft-Versus-Host disease drug be as effective as the pill?
- Scientists map immune battlefield in chronic GVHD tissue
- Could a rheumatoid arthritis drug tame chronic GVHD and cut steroid use?
- Could an arthritis drug tame a tough transplant complication?