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New drug cocktail aims to tame transplant complication

NCT ID NCT07285889

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called gecacitinib (jaktinib) combined with steroids as a first treatment for acute graft-versus-host disease (GVHD), a serious complication after stem cell transplants. About 35 adults who have had a stem cell transplant and develop moderate to severe GVHD will receive the drug combo. The goal is to find the safest and most effective dose and see how well it controls the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gecacitinib (also known as jaktinib) combined with glucocorticoids (steroids)
What this could lead to
If it works, this could point toward a more effective first-line treatment for acute graft-versus-host disease, potentially improving outcomes for stem cell transplant patients.
What could go wrong
This is an early-phase trial with only 35 participants, so results may not apply to everyone. The drug combination may cause side effects or fail to control the disease better than current treatments.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Voluntarily provide signed informed consent and be ≥18 years of age at the time of consent. 2. Recipients of allogeneic hematopoietic stem cell transplantation (allo-HSCT) using bone marrow, peripheral blood stem cells, or umbilical cord blood. 3. Have received systemic glucocorticoid therapy for no more than 2 days prior to enrollment. 4. Demonstrate clear myeloid and platelet engraftment: absolute neutrophil count (ANC) \> 1.0 × 10⁹/L and platelet count \> 50 × 10⁹/L (permitted use of growth factors or transfusion support). 5. Clinical diagnosis of grade II-IV acute GVHD (aGVHD) per the MAGIC (Mount Sinai Acute GVHD International Consortium) criteria (Appendix 1). 6. ECOG performance status of 0-2. 7. Life expectancy \> 4 weeks. 8. Able to swallow tablets. 9. Willing and able to comply with study procedures and follow-up. Exclusion Criteria: 1. History of ≥2 allo-HSCT procedures. 2. Development of aGVHD following unplanned donor lymphocyte infusion (DLI) for relapse of underlying malignancy. Note: Planned DLI as part of the transplant protocol is permitted. 3. Concurrent treatment with another JAK inhibitor. Note: Patients who previously discontinued JAK inhibitors due to toxicity (not refractory aGVHD) are eligible. 4. Active bleeding. 5. Diagnosed or suspected chronic GVHD. 6. Uncontrolled active infection, defined as sepsis-induced hemodynamic instability or progressive symptoms/signs/imaging findings attributable to infection. Asymptomatic or persistent fever alone is not exclusionary. 7. unresolved toxicity or complications from allo-HSCT (excluding aGVHD). 8. Clinically significant abnormalities that may compromise safety, including: a) Uncontrolled diabetes (fasting glucose \>13.9 mmol/L); b) Hypertension unresponsive to ≥2 agents (systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg); c) Peripheral neuropathy ≥Grade 2 (per NCI CTCAE v5.0). 9. Within 6 months prior to screening: NYHA Class III/IV heart failure, unstable angina, myocardial infarction, cerebrovascular accident, or pulmonary embolism. 10. Arrhythmia requiring treatment or QTcB interval \>480 ms at screening. 11. Severe renal impairment (serum creatinine \>1.5 × ULN) at screening. 12. Pre-transplant history of gastrointestinal ulcers, gastrectomy, or intestinal resection that may impair drug absorption. 13. Major surgery within 4 weeks prior to screening without full recovery. 14. Cholestatic disorders or hepatic sinusoidal obstruction syndrome (SOS/VOD) at screening (defined as persistent hyperbilirubinemia and organ dysfunction unrelated to GVHD). 15. Active uncontrolled viral infections at screening: HBV: HBsAg⁺ with detectable HBV-DNA, or detectable HBV-DNA regardless of HBsAg status; HCV: Anti-HCV antibody⁺ with detectable HCV-RNA. 16. History of active tuberculosis within 6 months prior to screening. 17. Epilepsy or current use of psychotropic/sedative medications. 18. Pregnancy, lactation, or intention to conceive; male patients unwilling to use condoms during treatment and for 2 days after the last dose. 19. Other active malignancies (excluding the transplanted hematologic malignancy) within 5 years. 20. Current use of anticoagulants or antiplatelet agents (except low molecular weight heparin). 21. Any condition that, in the investigator's judgment, may compromise patient safety or protocol compliance. 22. Known hypersensitivity to jaktinib, its analogs, or excipients. 23. Participation in another interventional clinical trial within 4 weeks prior to screening. 24. Investigator determination of unsuitability for the study.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • The First Affiliated Hospital, Zhejiang University School of Medicine.

    RECRUITING

    Hangzhou, Zhejiang, China

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