A Phase 1/2 interventional study of Jaktinib in Acute Graft vs Host Disease, sponsored by Nanfang Hospital, Southern Medical University. Not yet recruiting at 24 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Nanfang Hospital, Southern Medical University · Phase 1/2, Interventional, and Treatment
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).
Nanfang Hospital, Southern Medical University is the lead sponsor of 488 studies on the registry; 213 are open to participants now.
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Exclusion Criteria:
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
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.
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.
Time frame: Day 28
Durable overall response (DOR) at Day 56
The proportion of patients who had response at day 28 that was maintained at day 56.
Time frame: Day 56
Best Overall Response (BOR)
The proportion of patients who achieved a complete response or partial response at any time point up to and including Day 56 and before the start of additional systemic therapy for aGVHD.
Time frame: Day 56
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.
Time frame: Day 56
Overall Survival (OS)
The time from the date of enrollment to the date of death due to any cause.
Time frame: 1 year
Failure-Free Survival (FFS)
The time from the date of enrollment to date of hematologic disease relapse/progression, non-relapse mortality, or addition of new systemic aGvHD treatment.
Time frame: 1 year
Relapse-Free Survival (RFS)
The interval from enrollment to the date of death from any cause in the absence of hematologic disease relapse or progression.
Time frame: 1 year
Disease Relapse Rate
Cumulative incidence of hematological malignancy relapse or progression.
Time frame: 1 year
Event-Free Survival (EFS)
Time from the date of enrollment to the date of hematologic disease relapse/progression, graft failure, or death due to any cause.
Time frame: 1 year
Incidence of Chronic Graft-Versus-Host Disease (cGVHD)
Cumulative incidence of cGVHD post-allogeneic hematopoietic stem cell transplantation. cGvHD, defined as the diagnosis of any cGvHD including mild, moderate, severe.
Time frame: 1 year
Safety and Tolerability (TEAEs)
Evaluation of the safety and tolerability profiles of jaktinib, including the incidence of treatment-related adverse events (TRAEs).
Time frame: Treatment period to 28 days after the last dose of trial treatment.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jun 2027, 8 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Jaktinib
Nanfang Hospital, Southern Medical University →