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An Exploratory Clinical Study of GC012F Injection for Refractory gMG

NCT06419166 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2025-06-27

No results posted yet for this study

Summary

This study is a single-arm, open-label early exploratory clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of GC012F injection in subjects with refractory GMG. Additionally, the study aims to assess the pharmacokinetic (PK), pharmacodynamic (PD) characteristics, and immunogenicity of GC012F injection in subjects.

Conditions

  • Refractory Generalized Myasthenia Gravis

Interventions

DRUG

GC012F injection

Each subject will receive GC012F injection (CD19-BCMA CAR-T cells) once by intravenous infusion on Day 0. Other Name: CD19-BCMA CAR-T cells

Sponsors & Collaborators

  • Gracell Biotechnologies (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • Zhejiang University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2027-06-01
Completion
2027-10-01

Countries

  • China

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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 NCT06419166 on ClinicalTrials.gov