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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2023

Interventions

  • Drug: Jaktinib Hydrochloride Tablets
    • Oral on an empty stomach

Arms, Groups and Cohorts

  • Experimental: Jaktinib treatment
    • Participants began oral administration of Jaktinib at 75mg twice daily (BID); if stable after the first 3 days of treatment, the dose could be increased to 100mg BID Or continue 75mg BID treatment .

Clinical Trial Outcome Measures

Primary Measures

  • Overall Response Rate (ORR) at Day 28
    • Time Frame: Day 28
    • Defined as the percentage of participants demonstrating a complete response (CR), or partial response (PR).

Secondary Measures

  • Overall Survival (OS)
    • Time Frame: From the first day of Jaktinib treatment to death due to any cause,up to 24 months
    • Defined as the time from the first day of Jaktinib treatment to death due to any cause
  • Incidence and Severity of Adverse Events
    • Time Frame: From the first day of Jaktinib treatment to 28 days after end of treatment, up to 24 months

Participating in This Clinical Trial

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 Cockroft-Gault equation. – Known allergies, hypersensitivity, or intolerance to any of the study medications, excipients, or similar compounds.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Suzhou Zelgen Biopharmaceuticals Co.,Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yongping Song, PhD, Principal Investigator, Henan Tumor Hospital
  • Overall Contact(s)
    • Yongping Song, PhD, +86-0371-65587320, songyongping001@126.com

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