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GC012F in Patients With Autoimmune Diseases

NCT07072884 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-07-18

No results posted yet for this study

Summary

This is an open-label, early exploratory main clinical study to evaluate the safety and efficacy of GC012F Injection in subjects with autoimmune diseases (AID), as well as to assess its pharmacokinetic (PK) and pharmacodynamic (PD) profiles.

Conditions

  • Systemic Sclerosis (SSc)
  • Idiopathic Inflammatory Myopathy (IIM)

Interventions

DRUG

GC012F injection

Subjects who meet the CAR-T cell infusion criteria will receive GC012F Injection infusion within 48-72 hours after completion of lymphodepleting preconditioning.

Sponsors & Collaborators

  • Gracell Biotechnologies (Shanghai) Co., Ltd.

    collaborator INDUSTRY

  • Qiong Fu

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2027-03-31
Completion
2029-03-31

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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 NCT07072884 on ClinicalTrials.gov