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

NCT07185633 | Not Yet Recruiting Phase 2

• 1 other identifier: 20250824101854977
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

aGVHD

Keywords

GVHD; JAKi

Outcome Measures

Primary Outcomes (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

  Day 28

Study Arms (1)

Treatment group

EXPERIMENTAL

Gecacitinib-Corticosteroid as first-line therapy(Gecacitinib po. 50mg bid and Corticosteroid iv. 2mg/kg/d )

Drug: Gecacitinib-Corticosteroid; Drug: Methylprednisolone sodium succinate

Interventions

Gecacitinib-Corticosteroid DRUG

Gecacitinib po. 50mg bid at least 28 days

Treatment group

Methylprednisolone sodium succinate DRUG

Methylprednisolone sodium succinate IV 2mg/kg/d.

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Voluntarily sign informed consent form (ICF); age ≥18 years at ICF signing.
• \. Recipients who underwent non-myeloablative, myeloablative, or reduced-intensity allo-HSCT using bone marrow or peripheral blood stem cells.
• \. Have received systemic corticosteroid therapy for no more than 2 days (48 hours).
• \. 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).
• \. Clinical diagnosis of Grade II-IV aGVHD according to the MAGIC (Mount Sinai Acute GVHD International Consortium) criteria.
• \. ECOG performance status 0-2.
• \. Life expectancy greater than 4 weeks.
• \. Able to swallow tablets.
• \. Capable of complying with study and follow-up procedures.

You may not qualify if:

• \. Having undergone ≥2 allo-HSCT procedures.
• \. 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.\*
• \. Concurrent treatment with other JAK inhibitors.
• \. Presence of active bleeding.
• \. Diagnosed or suspected chronic GVHD.
• \. 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.
• \. Presence of 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 within SBP \<160 mmHg and DBP \<100 mmHg with two or more antihypertensive agents;
• Peripheral neuropathy (NCI-CTCAE v5.0 Grade 2 or higher).
• \. 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.
• \. Arrhythmia requiring treatment at screening, or QTc interval (QTcB) \>480 ms.
• \. Significant renal impairment at screening (serum creatinine \>1.5 × ULN).
• \. Pre-transplant diagnosed gastrointestinal ulcers, history of gastric/intestinal resection surgery, or other conditions potentially affecting drug absorption.

Sponsors & Collaborators

• Bin Gu: lead

Related Publications (3)

• 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.

  PMID: 39438467 RESULT

• 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.

  PMID: 35668528 RESULT

• 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.

  PMID: 33536914 RESULT

MeSH Terms

Interventions

Methylprednisolone Hemisuccinate

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 22, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09