NCT07303790

This is an Early Exploratory Study to Assess the Tolerability and Safety of GC012F in Patients With Multiple Sclerosis

An Early Exploratory Study to Assess the Tolerability and Safety of GC012F in Patients With Multiple Sclerosis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Daishi Tian · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an early exploratory study to assess the tolerability and safety of GC012F CAR T cell injection in Multiple Sclerosis patients.

Detailed description

This is a single-arm, open-label, early exploratory clinical study to evaluate the safety and efficacy of GC012F Injection in patients with MS, as well as to assess its PK and PD profiles. This study consists of the following periods: screening period, apheresis day, baseline period, lymphodepletion preconditioning period, GC012F infusion, safety and efficacy follow-up period, and long-term follow-up period. In this study, a single dose group is planned for the CAR-T cell infusion dose,and 15 evaluable subjects will be included. Eligible subjects will receive a single infusion of GC012F Injection and will be monitored for DLTs within 28 days following the infusion of GC012F Injection. After all the 6 subjects have completed DLT observation, all clinical study safety data collected during the DLT observation phase will be assessed. 9 subjects will be enrolled in the dose expansion phase. After CAR-T cell infusion, subjects will be followed up for safety, cell proliferation and survival, and efficacy until 672 days (96 weeks) after infusion, withdrawal from the study, death, withdrawal of informed consent, or lost to follow-up, whichever occurs first.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	GC012F CAR-T Cell Injection	A single dose group is planned for the CAR-T cell infusion dose is administrated for each subject.Single IV infusion.

Timeline

• Start date: 2026-01-16
• Primary completion: 2027-01-20
• Completion: 2028-12-10
• First posted: 2025-12-26
• Last updated: 2026-01-21

Locations

1 site across 1 country: China