Acute Graft Versus Host Disease Grade II-IVPhase 2GRITNCT07197112
Study of Gecacitinib in the Treatment of Acute Graft-Versus-Host Disease After Failure of Ruxolitinib-containing Second-line Therapy
A Phase 2 study testing Gecacitinib in people with Acute Graft Versus Host Disease Grade II-IV and Acute Graft vs Host Disease, run by Ruijin Hospital.
Trial summary
An open-label, single-arm clinical trial to evaluate the safety and efficacy of gecacitinib tablets in patients with acute graft-versus-host disease (GVHD) who have failed or are intolerant to ruxolitinib-containing second-line therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft Versus Host Disease Grade II-IV, Acute Graft vs Host Disease
- What is being tested?
- Gecacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 2027
- Phase
- Phase 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
- Voluntarily signed the informed consent form, with age ≥18 years at the time of ICF signing;
- Recipients who have undergone non-myeloablative, myeloablative, or reduced-intensity allo-HSCT (allogeneic hematopoietic stem cell transplantation) from any donor source (matched unrelated donor, sibling, or haploidentical) using bone marrow, peripheral blood stem cells, or umbilical cord blood;
- Complete donor engraftment: donor STR ≥95%, peripheral blood absolute neutrophil count (ANC) >0.5×10⁹/L, platelet count >25×10⁹/L (use of growth factors, transfusion support, etc., is permitted);
- aGVHD patients who have failed second-line treatment including ruxolitinib, defined as follows:
- GVHD progression: Progressive GVHD (i.e., an increase in the grading of any organ system or involvement of any new organ) compared to pre-ruxolitinib treatment, after receiving ruxolitinib therapy for ≥5 to 10 days;
- No response to treatment: Failure to achieve partial response or better improvement in GVHD compared to pre-treatment after at least 14 days of ruxolitinib therapy;
Show all 12Show fewer
- Loss of response: Objective worsening of GVHD (manifested as increased grading or new organ involvement) after initial improvement, occurring at any time point;
- Intolerance: Patients with stable or improving SR-aGVHD who discontinue ruxolitinib due to drug-related toxicity (as assessed by the treating physician).
- ECOG score: 0-2;
- Expected survival greater than 4 weeks;
- Ability to swallow tablets;
- Ability to comply with study and follow-up procedures.
Who cannot join
- Patients who have undergone ≥2 allo-HSCT procedures;
- Development of SR-aGVHD following unplanned donor lymphocyte infusion (DLI) administered for the treatment of malignant relapse. Note: Patients who received planned DLI as part of the transplant procedure, not intended for managing malignant relapse, may be enrolled;
- Prior use of ruxolitinib in combination with >1 systemic therapy for steroid-refractory aGVHD;
- Concurrent use of other JAK inhibitors besides ruxolitinib for treatment. Patients who discontinued JAK inhibitor therapy for aGVHD due to side effects rather than refractoriness are also eligible for the study;
- Patients with active bleeding;
- Patients diagnosed with or suspected of having chronic GVHD;
Show all 15Show fewer
- Presence of uncontrolled active infection. Uncontrolled active infection is defined as: hemodynamic instability due to sepsis, or worsening of symptoms, signs, or radiographic findings attributable to the infection. Persistent fever without symptoms or with resolving symptoms is not considered an uncontrolled active infection;
- Patients with unresolved toxicity or complications due to allo-HSCT (excluding aGVHD);
- Any significant clinical or laboratory abnormality that may affect safety evaluation, such as:
- Uncontrolled diabetes (fasting blood glucose >13.9 mmol/L);
- Hypertension that cannot be controlled to the following range (systolic blood pressure <160 mmHg, diastolic blood pressure <100 mmHg) with two or more antihypertensive agents;
- Peripheral neuropathy (NCI-CTCAE v5.0 Grade 2 or higher).
- History of New York Heart Association Class III or IV congestive heart failure, uncontrolled or unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism within 6 months prior to screening;
- Presence of arrhythmia requiring treatment at the time of screening, or patients with QTc interval (QTcB) >480 ms;
- Impaired renal function at screening (serum creatinine >1.5 × ULN);
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study of the Safety and Efficacy of Gimacabtinib Hydrochloride Tablets in Acute GVHD Patients After Failure of or Intolerance to Ruxolitinib-Based Second-Line Therapy.
An open-label, single-arm clinical trial to evaluate the safety and efficacy of gecacitinib tablets in patients with acute graft-versus-host disease (GVHD) who have failed or are intolerant to ruxolitinib-containing second-line therapy.
Read the detailed description
This is an open-label, single-arm study that plans to enroll 15 subjects with confirmed grade II-IV acute graft-versus-host disease (aGVHD). The primary endpoint is the overall response rate (ORR) on day 28 of gecacitinib treatment.
- Being tested
- Gecacitinib
- Keywords
- gecacitinib, II~IV aGVHD, allogeneic hematopoietic stem cell transplantation, ruxolitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GecacitinibDrug
Administer 50 mg twice daily for a minimum of 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Following enrollment, all subjects are planned to receive gecacitinib for at least 28 days while continuing their existing treatments. Receives: Drug: Gecacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Overall Response Rate at Day 28
Measured: Within 28 days of first dose
Secondary outcomes (1)
Non-recurrent Mortality Rate
Non-recurrent Mortality Rate at Week 4, Week 8, Week 12, Week 24
Measured: Week 4, Week 8, Week 12, Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft Versus Host Disease Grade II-IVStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoxia Hu, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07197112
- Sponsor's protocol ID
- RJ-BMT-GvHD-002
- Other IDs
- Self-funded
- Acronym
- GRIT
- Status last verified
- Aug 2025
- First submitted
- 19 Sep 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Safety and Efficacy of Gimacabtinib Hydrochloride Tablets in Acute GVHD Patients After Failure of or Intolerance to Ruxolitinib-Based Second-Line Therapy.
- ClinicalTrials.gov ID
- NCT07197112
- Acronym / sponsor ID
- GRIT / RJ-BMT-GvHD-002
- Keywords
- gecacitinib, II~IV aGVHD, allogeneic hematopoietic stem cell transplantation, ruxolitinib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An open-label, single-arm clinical trial to evaluate the safety and efficacy of gecacitinib tablets in patients with acute graft-versus-host disease (GVHD) who have failed or are intolerant to ruxolitinib-containing second-line therapy.
Detailed description
This is an open-label, single-arm study that plans to enroll 15 subjects with confirmed grade II-IV acute graft-versus-host disease (aGVHD). The primary endpoint is the overall response rate (ORR) on day 28 of gecacitinib treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: GecacitinibFollowing enrollment, all subjects are planned to receive gecacitinib for at least 28 days while continuing their existing treatments. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily signed the informed consent form, with age ≥18 years at the time of ICF signing;
- Recipients who have undergone non-myeloablative, myeloablative, or reduced-intensity allo-HSCT (allogeneic hematopoietic stem cell transplantation) from any donor source (matched unrelated donor, sibling, or haploidentical) using bone marrow, peripheral blood stem cells, or umbilical cord blood;
- Complete donor engraftment: donor STR ≥95%, peripheral blood absolute neutrophil count (ANC) >0.5×10⁹/L, platelet count >25×10⁹/L (use of growth factors, transfusion support, etc., is permitted);
- aGVHD patients who have failed second-line treatment including ruxolitinib, defined as follows:
- ECOG score: 0-2;
Key exclusion criteria (15 listed)
- Patients who have undergone ≥2 allo-HSCT procedures;
- Development of SR-aGVHD following unplanned donor lymphocyte infusion (DLI) administered for the treatment of malignant relapse. Note: Patients who received planned DLI as part of the transplant procedure, not intended for managing malignant relapse, may be enrolled;
- Prior use of ruxolitinib in combination with >1 systemic therapy for steroid-refractory aGVHD;
- Concurrent use of other JAK inhibitors besides ruxolitinib for treatment. Patients who discontinued JAK inhibitor therapy for aGVHD due to side effects rather than refractoriness are also eligible for the study;
- Patients with active bleeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GecacitinibAdminister 50 mg twice daily for a minimum of 28 days. | Drug | Experimental arm |
Primary outcome
Overall Response Rate
Time frame: Within 28 days of first dose
Overall Response Rate at Day 28
1 secondary outcome
Non-recurrent Mortality Rate
Time frame: Week 4, Week 8, Week 12, Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Related trials for Acute Graft Versus Host Disease Grade II-IV
RecruitingObservational study
Tissue, Blood, and Body Fluid Sample Collection From Patients With Hematologic Cancer
Chronic Myeloproliferative Disorders, Leukemia
Active, not recruitingObservational study
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Not yet recruitingPhase 1/2
Jaktinib for Steroid-Refractory Acute Graft-Versus-Host Disease
Acute Graft vs Host Disease
RecruitingPhase 2
Study of Gecacitinib-corticosteroid as First-line Therapy for Grade II-IV Acute Graft Versus Host Disease
aGVHD
Active, not recruitingPhase 4
Study of Efficacy and Safety of Ruxolitinib in Patients With Grade II to IV Steroid-refractory Acute Graft vs. Host Disease
Steroid-refractory Acute Graft Versus Host Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoxia Hu, MD principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gecacitinib in people with Acute Graft Versus Host Disease Grade II-IV and Acute Graft vs Host Disease, run by Ruijin Hospital.
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 12 inclusion and 15 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: opening soon, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
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?
Contact Xiaoxia Hu, MD (+86 021-64370045, hu_xiaoxia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Within 28 days of first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2025.