An Open-Label Study to Assess the Safety and Efficacy of GC012F in Patients With Multiple Sclerosis

Official Summary

This is an open-label,early-stage exploratory clinical study to evaluate the safety and preliminary efficacy of GC012F CAR T cell injection in Multiple Sclerosis subjects.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE

Interventions

• 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.

Primary Outcomes

• Dose-Limiting Toxicity (DLT) Rate (28 days)
• Adverse Events （AEs）Rate (Up to 15 years from treatment discontinuation)
• Iimmunoglobulins (Ig) levels in peripheral blood (Up to 15 years from treatment discontinuation)

Secondary Outcomes

• Peak blood and CSF concentration(Cmax)(Pharmacokinetic evaluation indicators) (Up to 36 months from treatment discontinuation)
• GC012F CAR gene copy number in peripheral blood and cerebrospinal fluid (CSF)(Pharmacodynamic evaluation indicators,) (Up to 36 months from treatment discontinuation)
• Changes in the concentration of soluble B-cell maturation antigen (BCMA) in peripheral blood (Up to 36 months from treatment discontinuation)
• Levels of Interleukins (IL-2, IL-6, IL-8, IL-10) (Up to 84 days from treatment discontinuation)
• Levels of Interferons-γ (IFN-γ) (Up to 84 days from treatment discontinuation)

Trial Locations

• Huashan Hospital Affiliated to Fudan University, Shanghai, Shanghai Municipality, China

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