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Acute Graft vs Host DiseasePhase 1/2NCT07885228

Jaktinib for Steroid-Refractory Acute Graft-Versus-Host Disease

A Phase 1/2 study testing Jaktinib in people with Acute Graft vs Host Disease, run by Nanfang Hospital, Southern Medical University at 24 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Graft-versus-host disease (GVHD) is a common severe complication and a primary cause of mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT).Previous studies have demonstrated that the JAK/STAT signaling pathway exerts anti-GVHD effects by reducing the expression of pro-inflammatory… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Acute Graft vs Host Disease
What is being tested?
Jaktinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
49 participants
Where
24 sitesChina
Study dates
10 Oct 2026to 10 Jun 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary written informed consent; aged 18 to 70 years, inclusive; male or female.
  • Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT) with documented myeloid engraftment.
  • Patients with grade II-IV steroid-refractory acute graft-versus-host disease (aGvHD).
  • Karnofsky Performance Status (KPS) score ≥ 60, with an expected survival of greater than 6 months.
  • Absence of uncontrolled infection or severe hepatic, renal, pulmonary, or cardiac disease.
  • Male participants must agree to practice abstinence or use contraception; female participants must have a negative pregnancy test and agree to use dual methods of contraception.
  • Able to swallow tablets.
  • Able to comply with study and follow-up procedures.

Who cannot join

  • Has received more than one systemic treatment for aGvHD other than corticosteroids +/- CNI (prophylaxis or treatment).
  • Has previously received chimeric antigen receptor (CAR) T-cell therapy.
  • Has previously received JAK inhibitor therapy after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
  • Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome with both acute and chronic GvHD features.
  • Failed prior alloHSCT within the past 6 months.
  • Presence of severe respiratory disease, severe renal impairment, clinically significant or uncontrolled cardiac disease, unresolved cholestasis, and hepatic disease (not attributable to aGvHD).
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  • Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present.Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection.
  • Evidence of active viral infection (confirmed by peripheral blood viral load) including CMV, EBV, HHV-6, HBV, or HCV. Patients with pre-transplant positive serology results indicative of high risk for viral reactivation must have negative viral load results within 28 days prior to enrollment. Patients whose immune status is unknown or uncertain (e.g. serologies not obtained prior to transplant) must have viral load results confirming no evidence of active viral infection within 28 days prior to enrollment.
  • Presence of relapsed primary malignancy, or who have been treated for relapse after the alloHSCT was performed, or who may require rapid immune suppression withdrawal as pre-emergent treatment of early malignancy relapse.
  • Has participated in any other clinical trials within 28 days before first administration.

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qifa Liu contact

+86-020-62787883

liuqifa628@163.com

Hua Jin contact

echohua1124@163.com

24 sites in 1 country

China24 sites

  • Peking University People's Hosptial

    Beijing, Beijing Municipality, 100044

  • Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)

    Changsha, Hunan, 410005

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • The First People's Hospital of Chenzhou

    Chenzhou, Hunan, 423000

  • Dongguan People's Hospital (The Tenth Affiliated Hospital of Southern Medical University)

    Dongguan, Guangdong, 523059

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350005

  • General Hospital of Southern Theater Command, PLA

    Guangzhou, Guangdong, 510010

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

  • Guangzhou First People's Hospital (The Second Affiliated Hospital of South China University of Technology)

    Guangzhou, Guangdong, 510180

  • Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)

    Guangzhou, Guangdong, 510317

  • Department of Hematology, Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Qifa Liu, PhD, +86-020-62787883, liuqifa628@163.com

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

  • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

    Hefei, Anhui, 230001

  • Huizhou Central People's Hospital

    Huizhou, Guangdong, 516001

  • Hebei Yanda Lu Daopei Hospital

    Langfang, Hebei, 065201

  • Maoming People's Hospital

    Maoming, Guangdong, 525000

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, 266003

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • Shenzhen People's Hospital

    Shenzhen, Guangdong, 518020

  • The Seventh Affiliated Hospital (Shenzhen), Sun Yat-sen University

    Shenzhen, Guangdong, 518107

  • Shenzhen Hospital of Southern Medical University

    Shenzhen, Guangdong, 518110

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: Safety and Efficacy of Jaktinib for Grade II-IV Steroid-Refractory Acute Graft-Versus-Host Disease (aGVHD)

Graft-versus-host disease (GVHD) is a common severe complication and a primary cause of mortality following allogeneic hematopoietic stem cell transplantation (allo-HSCT).Previous studies have demonstrated that the JAK/STAT signaling pathway exerts anti-GVHD effects by reducing the expression of pro-inflammatory cytokines, thereby inhibiting T-cell signaling transduction. Jaktinib is a broad-spectrum kinase inhibitor that targets non-receptor tyrosine Janus-associated kinases (JAK1, JAK2, JAK3, and TYK2), as well as FLT3 (FMS-like tyrosine kinase 3) and c-Kit. Preclinical studies indicated that Jaktinib significantly prolonged survival, mitigated weight loss, and improved clinical symptoms of GVHD in a dose-dependent manner in murine models.Based on this rationale, this prospective, single-arm, multicenter, exploratory clinical study was designed to evaluate the safety and efficacy of Jaktinib in the treatment of Grade II-IV steroid-refractory acute graft-versus-host disease (aGVHD).

Being tested
Jaktinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JaktinibDrug

    Beginning on Day 1, participants will receive jaktinib orally at the recommended phase 2 dose (RP2D) , until the earliest occurrence of clinically meaningful aGVHD progression (defined as disease progression necessitating the initiation of new systemic therapy for aGVHD), hematologic disease relapse, unacceptable AE, withdrawal of consent by the participant, investigator's decision to discontinue, or study completion, whichever occurs first.

Study groups in NCT07885228
Study groupRoleWhat they receive
Jaktinib ArmExperimentalEligible participants with Grade II-IV steroid-refractory acute graft-versus-host disease (SR-aGVHD) will be assigned to this single group. All patients in this arm will receive Jaktinib treatment to evaluate its safety and clinical efficacy.
Receives: Drug: Jaktinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate (ORR)

    The proportion of patients who had a complete response or partial response as compared with baseline organ staging without the use of additional systemic therapy for acute GVHD.

    Measured: Day 28

Secondary outcomes (10)

  1. Durable overall response (DOR) at Day 56

    The proportion of patients who had response at day 28 that was maintained at day 56.

    Measured: Day 56

  2. Best Overall Response (BOR)

    The proportion of patients who achieved a complete response or partial response at any time point up to and including Day 56 and before the start of additional systemic therapy for aGVHD.

    Measured: Day 56

  3. Overall response rate (ORR)

    The proportion of patients who had a complete response or partial response as compared with baseline organ staging without the use of additional systemic therapy for acute GVHD.

    Measured: Day 56

  4. Overall Survival (OS)

    The time from the date of enrollment to the date of death due to any cause.

    Measured: 1 year

  5. Failure-Free Survival (FFS)

    The time from the date of enrollment to date of hematologic disease relapse/progression, non-relapse mortality, or addition of new systemic aGvHD treatment.

    Measured: 1 year

  6. Relapse-Free Survival (RFS)

    The interval from enrollment to the date of death from any cause in the absence of hematologic disease relapse or progression.

    Measured: 1 year

  7. Disease Relapse Rate

    Cumulative incidence of hematological malignancy relapse or progression.

    Measured: 1 year

  8. Event-Free Survival (EFS)

    Time from the date of enrollment to the date of hematologic disease relapse/progression, graft failure, or death due to any cause.

    Measured: 1 year

  9. Incidence of Chronic Graft-Versus-Host Disease (cGVHD)

    Cumulative incidence of cGVHD post-allogeneic hematopoietic stem cell transplantation. cGvHD, defined as the diagnosis of any cGvHD including mild, moderate, severe.

    Measured: 1 year

  10. Safety and Tolerability (TEAEs)

    Evaluation of the safety and tolerability profiles of jaktinib, including the incidence of treatment-related adverse events (TRAEs).

    Measured: Treatment period to 28 days after the last dose of trial treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2026
  2. Study start10 Oct 2026 (estimated)
  3. Primary completion10 Jun 2027 (estimated)
  4. Study completion10 Jun 2028 (estimated)

Resources

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
49 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07885228
Sponsor's protocol ID
NFEC-2026-427
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Jaktinib in people with Acute Graft vs Host Disease, run by Nanfang Hospital, Southern Medical University at 24 sites in 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 8 inclusion and 10 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 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Qifa Liu (+86-020-62787883, liuqifa628@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) (time frame: Day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07885228.

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 21 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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