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Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases

NCT07322718 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-01-23

No results posted yet for this study

Summary

This Phase 1, open-label study evaluates the safety, tolerability, and preliminary efficacy of RXIM002, a CD19-targeting circular RNA-mediated in-vivo CAR T-cell therapy, in adults with severe, relapsed, or refractory B cell-mediated autoimmune diseases.

Conditions

  • Relapsed/Refractory B Cell-Mediated Autoimmune Diseases

Interventions

BIOLOGICAL

RXIM002 product

Prior to infusion of the RXIM002 product, subjects will receive pre-medication if needed

Sponsors & Collaborators

  • RiboX Therapeutics Ltd.

    collaborator INDUSTRY

  • Ruijin Hospital

    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
2025-12-24
Primary Completion
2027-12-19
Completion
2028-03-19

Countries

  • China

Study Locations

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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 NCT07322718 on ClinicalTrials.gov