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RN1201 Injection in the Treatment of Antibody-Mediated Diseases

NCT07072247 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-07-18

No results posted yet for this study

Summary

This single-arm, open-label exploratory trial aims to evaluate the safety, feasibility, and preliminary efficacy of RN1201 Injection in patients with antibody-mediated diseases, including refractory immune-mediated platelet transfusion refractoriness (PTR) and relapsed or refractory immune thrombocytopenia (ITP). Patients will receive RN1201 cells infusion following lymphodepletion. The study will assess safety, response rates, B-cell depletion, and immune reconstitution. Exploratory analyses will examine in vivo persistence and activity of RN1201.

Conditions

  • Refractory Immune-mediated Platelet Transfusion Refractoriness
  • Relapsed or Refractory Immune Thrombocytopenia

Interventions

GENETIC

CD19 and BCMA-targeted allogeneic CAR-T cells

Lymphodepletion chemotherapy followed by CD19 and BCMA-targeted allogeneic CAR-T cells infusion

Sponsors & Collaborators

  • Allorunning Therapeutics

    collaborator INDUSTRY

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-07-10
Primary Completion
2026-07-30
Completion
2027-07-30

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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 NCT07072247 on ClinicalTrials.gov