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aGVHDPhase 2NCT07185633

Study of Gecacitinib-corticosteroid as First-line Therapy for Grade II-IV Acute Graft Versus Host Disease

A Phase 2 study testing Gecacitinib-Corticosteroid and Methylprednisolone sodium succinate in people with aGVHD, run by Bin Gu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This trial employs a single-arm, single-center design, planning to enroll 25 patients diagnosed with grade II-IV aGVHD at one center. Patients meeting all inclusion criteria and no exclusion criteria will be enrolled. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
aGVHD
What is being tested?
Gecacitinib-Corticosteroid and Methylprednisolone sodium succinate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
1 Jan 2026to 1 Oct 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

  • 1. Voluntarily sign informed consent form (ICF); age ≥18 years at ICF signing.
  • 2. Recipients who underwent non-myeloablative, myeloablative, or reduced-intensity allo-HSCT using bone marrow or peripheral blood stem cells.
  • 3. Have received systemic corticosteroid therapy for no more than 2 days (48 hours).
  • 4. Documented myeloid and platelet engraftment: Absolute Neutrophil Count (ANC) >0.5 × 10⁹/L for 3 consecutive days, platelet count >20 × 10⁹/L for 7 consecutive days without transfusion support (use of growth factors, transfusion support allowed).
  • 5. Clinical diagnosis of Grade II-IV aGVHD according to the MAGIC (Mount Sinai Acute GVHD International Consortium) criteria.
  • 6. ECOG performance status 0-2.
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  • 7. Life expectancy greater than 4 weeks.
  • 8. Able to swallow tablets.
  • 9. Capable of complying with study and follow-up procedures.

Who cannot join

  • 1. Having undergone ≥2 allo-HSCT procedures.
  • 2. SR-aGVHD occurring after unplanned donor lymphocyte infusion (DLI) used for prophylactic treatment of malignancy relapse. *Note: Patients receiving planned DLI as part of the transplant procedure, not intended for managing malignancy relapse, may be included.*
  • 3. Concurrent treatment with other JAK inhibitors.
  • 4. Presence of active bleeding.
  • 5. Diagnosed or suspected chronic GVHD.
  • 6. Presence of uncontrolled active infection. Uncontrolled active infection is defined as: hemodynamic instability due to sepsis, or worsening of symptoms, signs, or radiographic findings due to infection. Persistent fever without symptoms or with stable symptoms is not considered an uncontrolled active infection.
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  • 7. Presence of unresolved toxicity or complications due to allo-HSCT (excluding aGVHD).
  • 8. 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 within SBP <160 mmHg and DBP <100 mmHg with two or more antihypertensive agents;
  • Peripheral neuropathy (NCI-CTCAE v5.0 Grade 2 or higher).
  • 9. History of NYHA Class III or IV congestive heart failure, uncontrolled or unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism within 6 months before screening.
  • 10. Arrhythmia requiring treatment at screening, or QTc interval (QTcB) >480 ms.
  • 11. Significant renal impairment at screening (serum creatinine >1.5 × ULN).
  • 12. Pre-transplant diagnosed gastrointestinal ulcers, history of gastric/intestinal resection surgery, or other conditions potentially affecting drug absorption.
  • 13. Surgery within 4 weeks before screening without full recovery.
  • 14. Cholestatic disease or hepatic sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) at screening (defined as persistent bilirubin abnormality and progressive organ dysfunction not due to GVHD).
  • 15. Active uncontrolled viral infection at screening, e.g., CMV, EBV, HIV (anti-HIV antibody positive), HBV (HBsAg positive, HBV-DNA positive), HCV (anti-HCV antibody or HCV-RNA positive).
  • 16. History of active tuberculosis within 6 months before screening.
  • 17. Epilepsy or use of psychotropic/sedative drugs at screening.
  • 18. Women planning pregnancy, pregnant, or breastfeeding, or patients unable to use effective contraception throughout the trial; male patients unwilling to use condoms during treatment and for 2 days (approx. 5 half-lives) after the last dose.
  • 19. History of other malignancies within the past 5 years, excluding the malignancy for which transplant was performed.
  • 20. Other severe comorbidities deemed by the investigator to potentially affect patient safety or compliance.
  • 21. Suspected allergy to gecacitinib, drugs of the same class, or any excipients.
  • 22. Participation in other investigational drug or medical device clinical trials within 4 weeks before screening.
  • 23. Any other condition considered by the investigator to preclude participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • No. 899 Pinghai Road, Gusu District, Suzhou City, Jiangsu Province, First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215100

    bin Gu, 0512-65223637, gubinsz@hotmail.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Single-Arm, Phase II Clinical Study of Gecacitinib-Corticosteroids as First-Line Treatment for Grade II-IV Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

This trial employs a single-arm, single-center design, planning to enroll 25 patients diagnosed with grade II-IV aGVHD at one center. Patients meeting all inclusion criteria and no exclusion criteria will be enrolled. After enrollment, all patients will receive Gecacitinib combined with methylprednisolone sodium succinate for at least 28 days.

After 28 days of Gecacitinib treatment, patients evaluated by the investigator as achieving Complete Response (CR) or Partial Response (PR) may continue study treatment for up to 24 weeks. If patients experience intolerance, disease progression, or require new systemic therapy, treatment will be adjusted.

Read the detailed description

All patients will receive the combined treatment of Gecacitinib and methylprednisolone sodium succinate in addition to the existing treatment regimen (Cyclosporin A 150~250 μg/L and/or Tacrolimus 5~12 μg/L) or other adjuvant treatments.

Dosage: Gecacitinib PO 50mg Bid; Methylprednisolone sodium succinate IV 2mg/kg/d.

After completing treatment, the Gecacitinib dose may be gradually reduced until discontinuation, per the investigator's discretion.The researchers adjusted the dosage of glucocorticoids according to the patient's condition: Methylprednisolone sodium succinate was gradually reduced.

If disease progresses (aGVHD grade increases by one level) during Gecacitinib treatment, the investigator should initiate other salvage therapy as clinically needed. If aGVHD efficacy evaluation does not reach Complete Response(CR) or Partial Response(PR) after 28 days of Gecacitinib, the investigator should initiate other systemic therapy as clinically needed.

Conditions
aGVHD
Being tested
Gecacitinib-Corticosteroid, Methylprednisolone sodium succinate
Keywords
GVHD, JAKi

What participants receive

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

  • Gecacitinib-CorticosteroidDrug

    Gecacitinib po. 50mg bid at least 28 days

  • Methylprednisolone sodium succinateDrug

    Methylprednisolone sodium succinate IV 2mg/kg/d.

Study groups in NCT07185633
Study groupRoleWhat they receive
Treatment groupExperimentalGecacitinib-Corticosteroid as first-line therapy(Gecacitinib po. 50mg bid and Corticosteroid iv. 2mg/kg/d )
Receives: Drug: Gecacitinib-Corticosteroid; Drug: Methylprednisolone sodium succinate

What is being measured

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

  1. Overall Response Rate (ORR) for aGVHD at Day 28 of treatment

    Defined as the percentage of patients achieving Complete Response (CR) + Partial Response (PR) at Day 28

    Measured: Day 28

Timeline

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

  1. First posted22 Sep 2025
  2. Study start1 Jan 2026
  3. Primary completion1 Oct 2027 (estimated)
  4. Study completion1 Oct 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07185633
Sponsor's protocol ID
20250824101854977
Status last verified
Sep 2026
First submitted
15 Sep 2025
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dou L, Zhao Y, Yang J, Deng L, Wang N, Zhang X, Liu Q, Yang Y, Wei Z, Wang F, Jiao Y, Li F, Luan S, Hu L, Gao S, Liu C, Liu X, Yan J, Zhang X, Zhou F, Lu P, Liu D. Ruxolitinib plus steroids for acute graft versus host disease: a multicenter, randomized, phase 3 trial. Signal Transduct Target Ther. 2024 Oct 23;9(1):288. doi: 10.1038/s41392-024-01987-x.

    PubMed 39438467

  • Dou L, Peng B, Li X, Wang L, Jia M, Xu L, Li F, Liu D. Ruxolitinib-corticosteroid as first-line therapy for newly diagnosed high-risk acute graft versus host disease: study protocol for a multicenter, randomized, phase II controlled trial. Trials. 2022 Jun 6;23(1):470. doi: 10.1186/s13063-022-06426-2.

    PubMed 35668528

  • Liu J, Lv B, Yin H, Zhu X, Wei H, Ding Y. A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, Multiple Ascending Dose and Food Effect Study to Evaluate the Tolerance, Pharmacokinetics of Jaktinib, a New Selective Janus Kinase Inhibitor in Healthy Chinese Volunteers. Front Pharmacol. 2020 Dec 14;11:604314. doi: 10.3389/fphar.2020.604314. eCollection 2020.

    PubMed 33536914

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gecacitinib-Corticosteroid and Methylprednisolone sodium succinate in people with aGVHD, run by Bin Gu at 1 site 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 9 inclusion and 26 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) for aGVHD at Day 28 of treatment (time frame: Day 28). 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 NCT07185633, which also lists 3 linked publications.

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 23 Sep 2026.

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