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

NCT07622329 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2026-06-03

No results posted yet for this study

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.

Conditions

  • Thrombocytopenic Purpura, Immune

Interventions

DRUG

JCXH-213

An mRNA-LNP based in vivo CAR therapy

Sponsors & Collaborators

  • The General Hospital of Western Theater Command

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-18
Primary Completion
2026-08-30
Completion
2027-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07622329 on ClinicalTrials.gov