cGVHDPhase 1/2CONTINUUM-GVHDNCT07476872
Gecacitinib in the Treatment of Steroid-Refractory/Dependent Chronic Graf Versus Host Disease (cGVHD).
A Phase 1/2 study testing Gecacitinib in people with cGVHD and HSCT, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study aims to evaluate the safety and efficacy of Gecacitinib in patients with steroid-refractory/dependent active chronic graft versus host disease (cGVHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Gecacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- 16 Mar 2026to 1 Nov 2028
- Phase
- Phase 1/2
- 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
- Age ≥ 18 years, regardless of gender.
- Underlying hematologic malignancies or non-malignant disorders having received allogeneic hematopoietic stem cell transplantation.
- Diagnosis of active cGVHD according to the 2014 NIH consensus criteria, meeting the definition of steroid-refractory or steroid-dependent cGVHD. Prior lines of cGVHD therapy are not restricted. Definitions are as follows:
- Steroid-refractory cGVHD is defined as meeting any of the following criteria: disease progression despite the use of prednisone ≥1 mg/kg/day (or equivalent dose of corticosteroids) for at least 1 week; OR, persistent disease symptoms with no improvement despite the use of prednisone ≥0.5 mg/kg/day or ≥1 mg/kg every other day (or equivalent dose of corticosteroids) for at least 4 weeks.
- Steroid-dependent cGVHD is defined as the requirement for a maintenance dose of prednisone >0.25 mg/kg/day or >0.5 mg/kg every other day (or equivalent dose of corticosteroids) to prevent disease flare or progression, and failure to successfully taper the dose to a lower level in at least 2 separate attempts spaced ≥8 weeks apart.
- Platelet count ≥50 × 10⁹/L and absolute neutrophil count (ANC) ≥0.5 × 10⁹/L, without the use of colony-stimulating factors, androgens, erythropoietin, thrombopoietin, or platelet transfusion within 7 days prior to screening.
Show all 10Show fewer
- Adequate major organ function, defined as meeting the following criteria: ALT and AST ≤ 2.5 × upper limit of normal (ULN); direct and total bilirubin ≤ 2.0 × ULN; serum creatinine ≤ 1.5 × ULN.
- Stable underlying disease without evidence of progression or relapse.
- Karnofsky Performance Status (KPS) ≥ 60%.
- Voluntarily participate in this study, provide signed informed consent, demonstrate good compliance, and be able to adhere to the study and follow-up procedures
Who cannot join
- Post-transplant lymphoproliferative disorder, or loss of full donor chimerism due to other reasons.
- Previous use of, or current treatment with, other JAK inhibitors at the time of screening.
- History or presence of major diseases or clinically significant organ dysfunction that cannot be adequately controlled by treatment and may interfere with study completion:
- Congestive heart failure of New York Heart Association (NYHA) class III-IV, or documented history of diastolic or systolic dysfunction (e.g., left ventricular ejection fraction <40% by echocardiography), or uncontrolled/unstable angina or myocardial infarction.
- Uncontrolled diabetes (blood glucose >250 mg/dL or >13.9 mmol/L).
- Hypertension that cannot be adequately controlled to systolic blood pressure <160 mmHg and diastolic blood pressure <100 mmHg despite combination antihypertensive therapy.
Show all 15Show fewer
- Peripheral neuropathy (Grade 2 or higher per NCI-CTCAE v5.0 criteria).
- Patients with any uncontrolled bacterial, viral, or fungal infection.
- Positive for HIV at screening, or active hepatitis B virus infection (HBsAg positive and HBV-DNA positive or above the upper limit of normal), or positive for HCV antibody with detectable HCV-RNA.
- History of tuberculosis or positive interferon-γ release assay at screening.
- Concurrent use of strong CYP3A4 inhibitors.
- History of progressive multifocal leukoencephalopathy.
- Known or suspected hypersensitivity to Gecacitinib hydrochloride, drugs of the same class, or any of their excipients.
- Pregnant or lactating women, or patients unwilling to use effective contraception during Gecacitinib treatment and for 1 week after the last dose.
- Inability to swallow oral tablets.
About this study
Official title: A Single-Arm, Open-Label, Single-Center Phase Ib/IIa Clinical Study of Gecacitinib in the Treatment of Steroid-Refractory/Dependent Active Chronic Graf Versus Host Disease (cGVHD).
This study aims to evaluate the safety and efficacy of Gecacitinib in patients with steroid-refractory/dependent active chronic graft versus host disease (cGVHD).
- Being tested
- Gecacitinib
- Keywords
- cGVHD, Gecacitinib, HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GecacitinibDrug
Phase Ib: Four dose cohorts of Gecacitinib are planned: 50 mg qd, 50 mg bid, 150 mg/day, and 100 mg bid. Dose escalation or de-escalation will follow the standard "3+3" design, starting at 50 mg BID. The dose may be escalated to 150 mg/day or 100 mg BID, or de-escalated to 50 mg qd. Subjects will receive continuous dosing for 28 days, or until they experience Dose-Limiting Toxicities (DLTs), cGVHD progression, or initiate new systemic therapy (whichever occurs first). Subjects who do not experience DLTs during Phase Ib may proceed to the Phase IIa dose-expansion stage.
Phase IIa: Subjects will receive Gecacitinib at the Recommended Phase II Dose (RP2D). Treatment will continue until the completion of 6 treatment cycles (each cycle is comprised of 4 weeks), or until the occurrence of intolerable toxicity, cGVHD progression, or initiation of new systemic therapy (whichever occurs first).
| Study group | Role | What they receive |
|---|---|---|
| Gecacitinib treatment | Experimental | Not described Receives: Drug: Gecacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
phase Ib: Maximal Tolerable Dose (MTD)
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD. (Patients in phase Ib)
Measured: Baseline up to 28 days
phase IIa: Overall response rate (ORR) on Cycle 7 Day 1
Percentage of participants achieving complete response (CR) and partial response (PR) during the study according to the cGVHD 2014 NIH Consensus Criteria.
Measured: Cycle 7 Day 1
Secondary outcomes (12)
phase Ib: Recommended phase II dose (RP2D)
Recommended dose for phase II (Patients in phase Ib)
Measured: Baseline up to 28 days
phase IIa: Rate of Failure-free Survival (FFS)
Composite time to event endpoint incorporating the following FFS events: (i) relapse or recurrence of underlying disease or death due to underlying disease, (ii) nonrelapse mortality, or (iii) addition or initiation of another systemic therapy for cGvHD.
Measured: Baseline to when the last participant reached Cycle 7 Day 1
phase IIa: Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score
To assess improvement of symptoms based on the total symptom score (TSS); a responder was defined as having achieved a clinically relevant reduction from Baseline of the TSS. The scale consists of 30 items in 7 subscales (skin, eye, mouth, lung, nutrition, energy, and psychological). Participants reported their level of symptom "bother" over the previous month on a 5-point likert scale: not at all, slightly, moderately, quite a bit, or extremely. Subscale scores and the summary score range from 0 to 100, with a higher score indicating worse symptoms
Measured: Cycle 7 Day 1
phase IIa: Best overall response (BOR)
BOR was defined as the percentage of participants who achieved an overall response (CR+PR) based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response at any time point (up to Cycle 7 Day 1 or the start of additional systemic therapy for cGvHD).
Measured: Cycle 7 Day 1
phase IIa: Proportion of patients who achieved ORR (CR+PR) at Cycle 4 Day 1.
ORR was defined as the percentage of participants in each arm demonstrating a CR or PR based on cGvHD disease assessments (National Institutes of Health Consensus Criteria) without the requirement of additional systemic therapies for an earlier progression, mixed response, or non-response.
Measured: Cycle 4 Day 1
phase IIa: Duration of Response (DOR)
Duration of response (DOR) is assessed for responders only. DOR is defined as the time from first response until cGvHD progression, death, or the date of change/addition of systemic therapies for cGvHD.
Measured: From first response until cGVHD progression, death, or the date of change/addition of systemic therapies for cGVHD, whichever comes first, assessed up to Cycle 7 Day 1.
phase IIa: Organ-Specific Response Rate
The proportion of patients who achieve organ-specific response, as defined by the 2014 NIH consensus criteria, in each involved organ at cycle 7 day 1.
Measured: Cycle 7 day 1
phase IIa: Proportion of patients with ≥50% reduction in daily steroid dose
Proportion of patients achieving a reduction in daily steroid dose by ≥50% sustained for at least 4 weeks.
Measured: Cycle 7 Day1
phase IIa: Proportion of patients successfully tapered off all steroids
Measured: Cycle 7 Day 1
phase IIa: Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)
Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The FACT-BMT is a 50-item self-report questionnaire that measures the effect of a therapy on domains including physical, functional, social/family, and emotional well-being, together with additional concerns relevant for bone marrow transplantation participants. The questions were based on a 5-point Likert scale, where 0 corresponds to "not at all" and 4 corresponds to "very much." The higher the final score, the better the quality of life. The FACT-BMT total score ranges from 0 to 148.
Measured: Baseline; up to Cycle 7 Day 1
phase IIa: Change From Baseline in EQ-5D-5L
The EQ-5D-5L is a descriptive classification consisting of five dimensions of health: mobility, self-care, usual activities, anxiety/depression, and pain/discomfort. The five-level version (no problems, slight problems, moderate problems, severe problems, and extreme problems) uses a 5-point Likert scale, with 1 being no problems and 5 being extreme problems.
Measured: Baseline; up to Cycle 7 Day 1
phase IIa: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Adverse events were defined as the appearance of (or worsening of any pre-existing) undesirable signs, symptoms, or medical conditions that occurred after the participant's signed informed consent was obtained. Abnormal laboratory values or test results occurring after informed consent constituted adverse events only if they induced clinical signs or symptoms, were considered clinically significant, required therapy, or required changes in study medication(s). TEAEs were defined as those AEs that started or worsened during the on-treatment period
Measured: From first dose to 28 days post last dose, up to Cycle 8 Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start16 Mar 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for cGVHDStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476872
- Sponsor's protocol ID
- IIT2026016
- Acronym
- CONTINUUM-GVHD
- Status last verified
- Mar 2026
- First submitted
- 26 Feb 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Single-Center Phase Ib/IIa Clinical Study of Gecacitinib in the Treatment of Steroid-Refractory/Dependent Active Chronic Graf Versus Host Disease (cGVHD).
- ClinicalTrials.gov ID
- NCT07476872
- Acronym / sponsor ID
- CONTINUUM-GVHD / IIT2026016
- Keywords
- cGVHD, Gecacitinib, HSCT
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 16 Mar 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and efficacy of Gecacitinib in patients with steroid-refractory/dependent active chronic graft versus host disease (cGVHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gecacitinib treatment | Experimental | Drug: Gecacitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years, regardless of gender.
- Underlying hematologic malignancies or non-malignant disorders having received allogeneic hematopoietic stem cell transplantation.
- Diagnosis of active cGVHD according to the 2014 NIH consensus criteria, meeting the definition of steroid-refractory or steroid-dependent cGVHD. Prior lines of cGVHD therapy are not restricted. Definitions are as follows:
- Platelet count ≥50 × 10⁹/L and absolute neutrophil count (ANC) ≥0.5 × 10⁹/L, without the use of colony-stimulating factors, androgens, erythropoietin, thrombopoietin, or platelet transfusion within 7 days prior to screening.
- Adequate major organ function, defined as meeting the following criteria: ALT and AST ≤ 2.5 × upper limit of normal (ULN); direct and total bilirubin ≤ 2.0 × ULN; serum creatinine ≤ 1.5 × ULN.
Key exclusion criteria (15 listed)
- Post-transplant lymphoproliferative disorder, or loss of full donor chimerism due to other reasons.
- Previous use of, or current treatment with, other JAK inhibitors at the time of screening.
- History or presence of major diseases or clinically significant organ dysfunction that cannot be adequately controlled by treatment and may interfere with study completion:
- Patients with any uncontrolled bacterial, viral, or fungal infection.
- Positive for HIV at screening, or active hepatitis B virus infection (HBsAg positive and HBV-DNA positive or above the upper limit of normal), or positive for HCV antibody with detectable HCV-RNA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GecacitinibPhase Ib: Four dose cohorts of Gecacitinib are planned: 50 mg qd, 50 mg bid, 150 mg/day, and 100 mg bid. Dose escalation or de-escalation will follow the standard "3+3" design, starting at 50 mg BID. The dose may be escalated to 150 mg/day or 100 mg BID, or de-escalated to 50 mg qd. Subjects will receive continuous dosing for 28 days, or until they experience Dose-Limiting Toxicities (DLTs), cGVHD progression, or initiate new systemic therapy (whichever occurs first). Subjects who do not experience DLTs during Phase Ib may proceed to the Phase IIa dose-expansion stage. Phase IIa: Subjects will receive Gecacitinib at the Recommended Phase II Dose (RP2D). Treatment will continue until the completion of 6 treatment cycles (each cycle is comprised of 4 weeks), or until the occurrence of intolerable toxicity, cGVHD progression, or initiation of new systemic therapy (whichever occurs first). | Drug | Gecacitinib treatment |
Primary outcome
phase Ib: Maximal Tolerable Dose (MTD)
Time frame: Baseline up to 28 days
If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD. (Patients in phase Ib)
phase IIa: Overall response rate (ORR) on Cycle 7 Day 1
Time frame: Cycle 7 Day 1
Percentage of participants achieving complete response (CR) and partial response (PR) during the study according to the cGVHD 2014 NIH Consensus Criteria.
12 secondary outcomes
phase Ib: Recommended phase II dose (RP2D)
Time frame: Baseline up to 28 days
phase IIa: Rate of Failure-free Survival (FFS)
Time frame: Baseline to when the last participant reached Cycle 7 Day 1
phase IIa: Rate of Participants With Clinically Relevant Improvement of the Modified Lee cGvHD Symptom Scale Score
Time frame: Cycle 7 Day 1
phase IIa: Best overall response (BOR)
Time frame: Cycle 7 Day 1
phase IIa: Proportion of patients who achieved ORR (CR+PR) at Cycle 4 Day 1.
Time frame: Cycle 4 Day 1
phase IIa: Duration of Response (DOR)
Time frame: From first response until cGVHD progression, death, or the date of change/addition of systemic therapies for cGVHD, whichever comes first, assessed up to Cycle 7 Day 1.
phase IIa: Organ-Specific Response Rate
Time frame: Cycle 7 day 1
phase IIa: Proportion of patients with ≥50% reduction in daily steroid dose
Time frame: Cycle 7 Day1
phase IIa: Proportion of patients successfully tapered off all steroids
Time frame: Cycle 7 Day 1
phase IIa: Change From Baseline in Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT)
Time frame: Baseline; up to Cycle 7 Day 1
phase IIa: Change From Baseline in EQ-5D-5L
Time frame: Baseline; up to Cycle 7 Day 1
phase IIa: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
Time frame: From first dose to 28 days post last dose, up to Cycle 8 Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
Related trials for cGVHD
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gecacitinib in people with cGVHD and HSCT, run by Institute of Hematology & Blood Diseases Hospital, 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 10 inclusion and 15 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: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phase Ib: Maximal Tolerable Dose (MTD) (time frame: Baseline up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2026.