A Clinical Study to Evaluate JCXH-213 in the Treatment of Adults With Primary Immune Thrombocytopenia

Summary

This is an open-label, single-arm, dose-escalation study designed to evaluate the safety, tolerability, recommended subsequent dose, pharmacokinetic profile, and preliminary efficacy of JCXH-213 in adult patients with primary immune thrombocytopenia (ITP) who are refractory or relapsed after treatment with corticosteroids and second-line therapies. The study consists of a screening period, treatment period, end-of-treatment visit, safety follow-up, and study withdrawal visit. Two dose groups are planned: 2 mg and 4 mg, with 2 patients to be enrolled in each dose group. During the treatment period, JCXH-213 at the assigned dose will be administered once every other day for a total of 7 doses. Assessments for safety and efficacy will be conducted according to the study schedule. After the last dose, patients will undergo an end-of-treatment visit and safety follow-up until the end of the study.

Timeline

Start

2026-06-18

Primary completion

2026-08-30

Completion

2027-06-30

Drugs

Indications