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

NCT07885228 | Not Yet Recruiting Phase 1

• 1 other identifier: NFEC-2026-427
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 24

Brief 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 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).

Conditions

Acute Graft vs Host Disease

Outcome Measures

Primary Outcomes (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.

  Day 28

Secondary Outcomes (10)

• Durable overall response (DOR) at Day 56

  Day 56

• Best Overall Response (BOR)

  Day 56

• Overall response rate (ORR)

  Day 56

• Overall Survival (OS)

  1 year

• Failure-Free Survival (FFS)

  1 year

Study Arms (1)

Jaktinib Arm

EXPERIMENTAL

Eligible 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.

Drug: Jaktinib

Interventions

Jaktinib DRUG

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.

Jaktinib Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: collaborator

Study Sites (24)

The First Affiliated Hospital of USTC (Anhui Provincial Hospital)

Hefei, Anhui, 230001, China

Location

Peking University People's Hosptial

Beijing, Beijing Municipality, 100044, China

Location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350005, China

Location

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

Dongguan, Guangdong, 523059, China

Location

General Hospital of Southern Theater Command, PLA

Guangzhou, Guangdong, 510010, China

Location

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

Guangzhou, Guangdong, 510120, China

Location

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

Guangzhou, Guangdong, 510180, China

Location

Guangdong Second Provincial General Hospital (Guangdong Provincial Emergency Hospital)

Guangzhou, Guangdong, 510317, China

Location

Department of Hematology, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Huizhou Central People's Hospital

Huizhou, Guangdong, 516001, China

Location

Maoming People's Hospital

Maoming, Guangdong, 525000, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

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

Shenzhen, Guangdong, 518107, China

Location

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518110, China

Location

Hebei Yanda Lu Daopei Hospital

Langfang, Hebei, 065201, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

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

Wuhan, Hubei, 430022, China

Location

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

Wuhan, Hubei, 430030, China

Location

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

Changsha, Hunan, 410005, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

Location

The First People's Hospital of Chenzhou

Chenzhou, Hunan, 423000, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266003, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Central Study Contacts

Qifa Liu

CONTACT

+86-020-62787883; liuqifa628@163.com

Hua Jin

CONTACT

echohua1124@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2026
• First Posted: October 21, 2026
• Study Start: October 10, 2026
• Primary Completion (Estimated): June 10, 2027
• Study Completion (Estimated): June 10, 2028
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (24)