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

Z

Zelgen Biopharmaceuticals

Status and phase

Not yet enrolling
Phase 2

Conditions

Acute Graft-Versus-Host Disease

Treatments

Drug: Jaktinib Hydrochloride Tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT04971551
ZGJAK013

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Jaktinib treatment
Experimental group
Description:
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 .
Treatment:
Drug: Jaktinib Hydrochloride Tablets

Trial contacts and locations

1

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Central trial contact

Yongping Song, PhD

Data sourced from clinicaltrials.gov

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