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RN1201 Injection for Autoimmune Diseases Refractory to Standard Therapies

NCT07105735 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-08-06

No results posted yet for this study

Summary

This is a open-label, exploratory trial to evaluate the safety, feasibility, and preliminary efficacy of RN1201, an Allogeneic CAR-T cell therapy, in patients with autoimmune diseases refractory to standard treatment. Eligible patients with moderate to severe activity of diseases will receive a single infusion of RN1201 following lymphodepletion. Primary endpoints include dose-limiting toxicity and treatment-emergent adverse events. Secondary and exploratory endpoints assess clinical response and cell pharmacokinetics.

Conditions

  • Autoimmune Diseases Refractory to Standard Therapies

Interventions

BIOLOGICAL

allogeneic CAR-T

Fludarabine injection (30 mg/m2，QD×3d) and cyclophosphamide injection (300 mg/m2，QD×3d)will be used to remove the lymphocyte before RN1201 infusion.

Sponsors & Collaborators

  • Rui Therapeutics Co., Ltd

    collaborator INDUSTRY

  • Allorunning Therapeutics

    collaborator INDUSTRY

  • The First Affiliated Hospital with Nanjing Medical University

    lead OTHER

Principal Investigators

  • Lei Fan · The First Affiliated Hospital with Nanjing Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-31
Primary Completion
2027-08-31
Completion
2027-12-31

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 NCT07105735 on ClinicalTrials.gov