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

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