Trial reportSignal transduction and targeted therapy2026
Novel highly selective ROCK2 inhibitor (TDI01) for the treatment of chronic graft-versus-host disease: a multicenter, open-label phase Ib/II study.
Trial report in Signal transduction and targeted therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06169722 (TDI01 for Treatment of Moderate or Severe Chronic Graft-Versus-Host Disease After Failure of at Least 1 and Not More Than 5 Lines of Systemic Therapy), which is not on this map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
TDI01 for Treatment of Moderate or Severe Chronic Graft-Versus-Host Disease After Failure of at Least 1 and Not More Than 5 Lines of Systemic Therapy: an Open Label, Multi-center, ph1/2 Study
Who cites it
1 citing paper in PubMed.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Chronic graft-versus-host disease (cGVHD) remains a major complication following allogeneic hematopoietic stem cell transplantation for long-term survival. Emerging evidence highlights Rho-associated coiled-coil kinase 2 (ROCK2) as a promising therapeutic target for cGVHD, which can modulate immune responses and profibrotic reactions. TDI01, a potent and highly selective ROCK2 inhibitor, represents a potential breakthrough in cGVHD treatment. This was the dose-finding, phase Ib portion of a multicenter, open-label phase Ib/II study (NCT06169722) designed to evaluate the safety and preliminary efficacy of TDI01 in patients with moderate-to-severe cGVHD after failure of 1 to 5 prior therapies. Sixty patients were enrolled in two once-daily dosing cohorts: 200 mg (n = 30) and 400 mg (n = 30). The primary endpoints were the 24-week best overall response rate (BORR) and safety. As of January 17, 2025, 57 patients were evaluated for efficacy. The 24-week BORRs were 67.9% (200 mg cohort) and 86.2% (400 mg cohort), with an overall BORR of 77.2%. The median times to response were 44.5 days (200 mg cohort) and 30.0 days (400 mg cohort). Neither the median duration of response nor the median failure-free survival (FFS) was achieved. The probability of FFS at 24 weeks was 83.9%. The most common adverse events ( ≥ 20% of patients) were transient bilirubin elevation (total bilirubin elevation 81.7%, unconjugated 56.7%, conjugated 45.0%) and headache (23.3%), without significant increases in liver enzymes. Thus, TDI01, particularly at the 400 mg QD dose, demonstrated promising efficacy and safety in moderate-to-severe cGVHD, which will be confirmed in a forthcoming phase III randomized controlled trial.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.