Actively Recruiting
This is an Early Exploratory Study to Assess the Tolerability and Safety of GC012F in Patients With Multiple Sclerosis
Led by Daishi Tian · Updated on 2026-01-21
15
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an early exploratory study to assess the tolerability and safety of GC012F CAR T cell injection in Multiple Sclerosis patients.
CONDITIONS
Official Title
This is an Early Exploratory Study to Assess the Tolerability and Safety of GC012F in Patients With Multiple Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Laboratory tests at screening must meet specific blood count, liver, kidney, heart, and oxygen levels requirements
- Confirmed diagnosis of Multiple Sclerosis based on 2017 McDonald criteria and 2013 Lublin phenotype criteria
- Relapsing-remitting MS patients must have failed at least one highly effective disease-modifying therapy and show recent clinical relapses or MRI activity
- Primary and secondary progressive MS patients must have failed highly effective therapy with recent disease worsening and no MRI lesions
- Expanded Disability Status Scale (EDSS) score between 2.0 and 6.5
- Documented presence of oligoclonal bands or elevated IgG index in cerebrospinal fluid
You will not qualify if you...
- Active uncontrolled infections requiring hospitalization or intravenous treatment within 4 weeks prior to screening
- Active or untreated latent tuberculosis
- History of severe allergies or hypersensitivity
- Primary immunodeficiency disorders
- Impaired cardiac function or significant heart disease
- Serious respiratory diseases including moderate to severe asthma or pulmonary fibrosis
- Current or history of liver cirrhosis
- Recent autoimmune diseases requiring continuous systemic immunosuppressants
- Active malignancy or recent history of cancer within 5 years, with specific exceptions
- Significant bleeding symptoms or blood clot events within 6 months prior to screening
- Hematologic disorders such as myelodysplastic syndrome or sickle-cell anemia
- Severe neurological or mental health disorders affecting safety or assessments
- Positive tests for HIV, active hepatitis B or C infection, HTLV, or syphilis
- Recent live attenuated vaccine within 4 weeks prior to apheresis
- Recent participation in other investigational drug trials within 4 weeks prior to apheresis
- Splenectomy within 12 months prior to informed consent
- Prior therapies targeting CD19, BCMA, or CAR T-cell therapies
- Recent use of specific MS drugs (rituximab, ofatumumab, siponimod, ozanimod, fingolimod, teriflunomide) within specified timeframes
- Major surgery within 8 weeks prior to consent or planned surgery during the study with exceptions
- History of organ transplantation
- Diagnosed monophasic disease or other non-MS demyelinating disorders
- History of neuromyelitis optica spectrum disorder or related neurological diseases
- History or presence of CNS or spinal cord tumors or progressive neurological diseases interfering with assessments
- CNS disorders that could interfere with neurotoxicity assessment
- History of seizures regardless of control status
- MS lesions or symptoms that increase neurotoxicity risk
- Any contraindications to lumbar puncture including structural spine abnormalities, bleeding risks, or anticoagulant use without safe discontinuation
- Inability or unwillingness to undergo MRI due to claustrophobia or contraindications
- Initiation of new disease-modifying therapy between apheresis and lymphodepletion
- Any conditions judged by the investigator to hinder full participation or compromise study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology
Hubei, Hubei, China, 430030
Actively Recruiting
Research Team
D
Daishi Tian, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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