A Study of Jaktinib for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

Acute Graft-Versus-Host Disease Clinical Trial

Official title:

A Phase 2 ,Safety and Efficacy Study of Jaktinib Hydrochloride Tablets for the Treatment of Steroid-Refractory Acute Graft-Versus-Host Disease.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04971551
• Other study ID #: ZGJAK013
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 2024
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: Suzhou Zelgen Biopharmaceuticals Co.,Ltd
• Contact: Yongping Song, PhD
• Phone: +86-0371-65587320
• Email: songyongping001[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an single-arm, Phase II multi-center study. The purpose of this study is to assess the efficacy and safety of Jaktinib in subjects with Grades II to IV steroid-refractory acute graft-versus-host disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible.

• Clinically suspected Grades II to IV acute GVHD according to NCCN guidelines 2020 V2.0, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic program.

• Subjects with steroid-refractory acute GVHD, defined as any of the following:

Subjects with progressive GVHD (ie, increase in stage in any organ system or any new organ involvement) after 3-5 days of primary treatment with methylprednisolone = 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors(CNI);Subjects with GVHD that has not improved (ie, decrease in stage in at least 1 involved organ system) after 5-7 days of primary treatment with methylprednisolone = 2 mg/kg per day (or equivalent) ± Calcineurin inhibitors(CNI);Subjects who Corticosteroid dependence(ie, begin corticosteroids at 2.0 mg/kg per day, demonstrate response, but progress before decrease from the initial starting dose of corticosteroids is achieved).

• ECOG: 0-2;

• Life expectancy > 4 weeks;

• Ability for oral drug intake;

• Willingness to comply with all study visits and procedures.

Exclusion Criteria:

• Has received more than 2 allo-HSCT.

• Acute GvHD occurring after non-scheduled donor leukocyte infusion (DLI) administered.

• Has received more than 1 systemic treatment in addition to corticosteroids for acute GVHD.

• Presence of an active uncontrolled infection.

• Serum creatinine > 1.5 ULN or creatinine clearance < 30 mL/min calculated by Cockcroft-Gault equation.

• Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Related Conditions & MeSH terms

• Acute Graft-Versus-Host Disease
• Graft vs Host Disease

Intervention

Drug:
• Jaktinib Hydrochloride Tablets
Oral on an empty stomach

Locations

Country	Name	City	State
China	Henan Tumor Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR) at Day 28	Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR).	Day 28
Secondary	Overall Survival (OS)	Defined as the time from the first day of Jaktinib treatment to death due to any cause	From the first day of Jaktinib treatment to death due to any cause,up to 24 months
Secondary	Incidence and Severity of Adverse Events		From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months