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Dual Target CAR-T Cell Treatment for Refractory Systemic Lupus Erythematosus (SLE) Patients

NCT05858684 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-05-15

No results posted yet for this study

Summary

This is an early exploratory phase, single arm, non-randomized, open label, treatment study trial to determine the maximum tolerated dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.

Conditions

  • CAR-T Cell Therapy

Interventions

DRUG

GC012F injection

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

Sponsors & Collaborators

  • Gracell Biotechnologies (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2023-11-10
Completion
2025-05-10

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 NCT05858684 on ClinicalTrials.gov