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

NCT07303790 | Recruiting Early Phase 1 DMC

• 1 other identifier: D831DN00001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; CAR-T cell therapy

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity (DLT) Rate

  DLT is defined as an AE that occurs within 28 days of GC012F CAR-T product reinfusion.DLT will be evaluated according to NCI-CTCAE V5.0 criteria.

  28 days

• Adverse Events （AEs）Rate

  Proportion of subjects experiencing AE within 15 years after infusion of GC012F CAR-T cell injection.

  Up to 15 years from treatment discontinuation

Secondary Outcomes (19)

• GC012F T cell count in peripheral blood and cerebrospinal fluid (CSF)(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

• Iimmunoglobulins (Ig) levels in peripheral blood

  Up to 15 years from treatment discontinuation

Study Arms (1)

GC012F CAR-T Cell Injection

EXPERIMENTAL

This study is an early exploratory. The main purpose is an IIT clinical trial to evaluate the safety and efficacy of GC012F dual CAR-T injection in Multiple Sclerosis patinents . The enrolled patients were patients with Multiple Sclerosis .

Drug: GC012F CAR-T Cell Injection

Interventions

GC012F CAR-T Cell Injection DRUG

A single dose group is planned for the CAR-T cell infusion dose is administrated for each subject.Single IV infusion.

GC012F CAR-T Cell Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The laboratory test results at screening must meet the following criteria:
• a)Absolute neutrophil count ≥ 1.0 × 10\^9/L (no growth factor is given for supportive care within 7 days prior to testing);
• b)Absolute lymphocyte count ≥ 1.0×10\^9/L;
• c)Hemoglobin ≥ 80 g/L (no red blood cell transfusion is given within 7 days prior to testing);
• d)Platelet count ≥ 50×10\^9/L (no blood transfusion is given within 7 days prior to testing);
• e)Serum IgG ≥ 500 mg/dL;
• f)Activated partial thromboplastin time ≤ 1.5 × upper limit of normal (ULN), prothrombin time (PT) ≤ 1.5 × ULN;
• g)Adequate renal, hepatic, cardiopulmonary function : i.Serum alanine aminotransferase and aspartate aminotransferase ≤ 3 × ULN; ii.Total bilirubin \< 2 × ULN (direct bilirubin ≤ 1.5 × ULN for subjects with Gilbert's syndrome); iii.Creatinine ≤ 2 mg/dL or creatinine clearance ≥ 60 mL/min (estimated according to the Cockcroft Gault formula); iv.Subjects with left ventricular ejection fraction ≥ 45% (performed within 8 weeks prior to apheresis) as diagnosed by echocardiography (ECHO) or multi-gated acquisition scan and no evidence of pericardial effusion as determined by ECHO and no clinically significant electrocardiographic findings; v.Baseline oxygen saturation \> 92% under indoor air conditions; vi.Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m\^2.
• Confirmed diagnosis of MS based on the 2017 McDonald diagnostic criteria and diagnosis of relapsing or progressive MS based on the 2013 Lublin phenotype criteria for multiple sclerosis;
• Relapsing-remitting multiple sclerosis (RRMS):
• patients with RRMS who have failed ≥ 1 highly effective disease modifying therapy (DMT) (fingolimod, siponimod, ozanimod, and anti-leukocyte cluster of differentiation \[CD\] 20 monoclonal antibody therapy, etc.) (defined as at least 12 months of continuous use).
• At least 2 clinical relapses in the past 2 years, or 1 clinical relapse in the past 2 years with ≥ 1 new Gd-enhancing lesion on MRI, or ≥ 1 new Gd-enhancing lesion on MRI within the past 6 months; c) ≥ 2 Gd-enhancing lesions on T1-weighted brain MRI at screening.
• Primary progressive multiple sclerosis (PPMS):
• patients with primary progressive MS who have failed highly effective DMT and whose disease activity has worsened recently (i.e., within 1 year) (EDSS disease progression score ≥ 0.5);
• no Gd-enhancing lesions on brain MRI at screening.

You may not qualify if:

• Fungal, bacterial, viral, or other infection not controlled and/or requiring hospitalization or intravenous antimicrobial therapy within 4 weeks prior to screening. Uncomplicated urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to current therapy;
• Active tuberculosis or latent tuberculosis that has not been treated appropriately prior to screening;
• History of severe hypersensitivity or allergy;
• Primary immunodeficiency;
• Impaired cardiac function or clinically significant cardiac disease;
• History of serious respiratory diseases or current serious respiratory diseases, including moderate or severe or above asthma or chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary fibrosis;
• Current or history of cirrhosis;
• History of Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus within the past 2 years, and the need for continuous use of systemic immunosuppressants/systemic disease-modifying drugs;
• Any active malignancy or history of malignancy within 5 years prior to screening. The following are exceptions: early-stage tumors that have undergone radical treatment (carcinoma in situ or stage I tumors, non-ulcerative primary melanoma with a depth \< 1 mm and no lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, thyroid carcinoma in situ or early-stage thyroid cancer that has undergone radical treatment, cervical carcinoma in situ, or breast cancer in situ that has undergone potentially radical treatment;
• Those who have clinically significant bleeding symptoms or definite haemorrhagic diathesis within 6 months prior to screening;
• Arterial or venous thrombotic events such as cerebrovascular disorders (including cerebral hemorrhage, cerebral infarction, etc), deep venous thrombosis, and/or pulmonary embolism within 6 months prior to screening;
• Hematologic disorders: History of cytopenia consistent with myelodysplastic syndrome; history of sickle-cell anemia or other hemoglobinopathies;
• Severe underlying medical conditions, such as:
• Significant clinical evidence of dementia or mental status changes;
• History of any other central nervous system (CNS) disorders or neurodegenerative diseases, such as epilepsy, seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, and psychosis;

Sponsors & Collaborators

• Daishi Tian: lead

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science & Technology

Hubei, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Daishi Tian, Ph.D.

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daishi Tian, Ph.D.

CONTACT

+8613607178809; tiands@tjh.tjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: In this study, a single dose group is planned for the CAR-T cell infusion dose.Among them, 6 subjects will be enrolled in the DLT observation phase, and 9 subjects will be enrolled in the expansion phase.

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 26, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): December 10, 2028
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)