New drug cocktail aims to tame transplant complication
NCT ID NCT07285889
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- 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: 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.
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The places running it
1 site. 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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The First Affiliated Hospital, Zhejiang University School of Medicine.
RECRUITINGHangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a lung protein tame severe graft-versus-host disease?
- Combination drug approach aims to tame immune attack after stem cell transplant
- New shot may shield transplant patients from deadly immune attack
- New drug shows promise in controlling transplant complications
- Poop pills may tame deadly transplant complication