Study of Gecacitinib in the Treatment of Acute Graft-Versus-Host Disease After Failure of Ruxolitinib-containing Second-line Therapy (GRIT)

September 19, 2025 updated by: Ruijin Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntarily signed the informed consent form, with age ≥18 years at the time of ICF signing;
  2. 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;
  3. 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);

  4. 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;
    • 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).
  5. ECOG score: 0-2;
  6. Expected survival greater than 4 weeks;
  7. Ability to swallow tablets;
  8. Ability to comply with study and follow-up procedures.

Exclusion Criteria:

  1. Patients who have undergone ≥2 allo-HSCT procedures;
  2. 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;
  3. Prior use of ruxolitinib in combination with >1 systemic therapy for steroid-refractory aGVHD;
  4. 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;
  5. Patients with active bleeding;
  6. Patients diagnosed with or suspected of having chronic GVHD;
  7. 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;
  8. Patients with unresolved toxicity or complications due to allo-HSCT (excluding aGVHD);

  9. Any significant clinical or laboratory abnormality that may affect safety evaluation, such as:

    1. Uncontrolled diabetes (fasting blood glucose >13.9 mmol/L);
    2. 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;
    3. Peripheral neuropathy (NCI-CTCAE v5.0 Grade 2 or higher).
  10. 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;
  11. Presence of arrhythmia requiring treatment at the time of screening, or patients with QTc interval (QTcB) >480 ms;
  12. Impaired renal function at screening (serum creatinine >1.5 × ULN);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental arm
Following enrollment, all subjects are planned to receive gecacitinib for at least 28 days while continuing their existing treatments.
Drug: Gecacitinib
Administer 50 mg twice daily for a minimum of 28 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall Response Rate
Time Frame: Within 28 days of first dose
Overall Response Rate at Day 28
Within 28 days of first dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Non-recurrent Mortality Rate
Time Frame: Week 4, Week 8, Week 12, Week 24
Non-recurrent Mortality Rate at Week 4, Week 8, Week 12, Week 24
Week 4, Week 8, Week 12, Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaoxia Hu, MD, Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RJ-BMT-GvHD-002
  • Self-funded (Other Identifier: The British University in Egypt)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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