Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Inflammatory Diseases of the Nervous System

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

September 22, 2020

Primary Completion Date

February 22, 2027

Study Completion Date

May 31, 2027

Conditions
Autoimmune DiseasesAutoimmune Diseases of the Nervous SystemNeuromyelitis Optica Spectrum DisorderMyasthenia GravisChronic Inflammatory Demyelinating PolyradiculoneuropathyIdiopathic Inflammatory MyopathiesMultiple SclerosisAutoimmune EncephalitisMyelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)POEMS Syndrome
Interventions
BIOLOGICAL

CT103A cells

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture CT103A cells, during which cyclophosphamide will be administered for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with CT103A cells by intravenous (IV) infusion. The initial dose of 0.5×10\^6 CAR+ T cells/kg will be infused on day 0.

DRUG

Cyclophosphamide and fludarabine

"Subjects will receive one 3-day cycle of lymphodepletion starting 4 days prior to CT103A infusion on Day 0.~Subjects will be given IV infusion of cyclophosphamide 300 mg/m2/day on day -4, -3 and -2, and fludarabine 30 mg/m2 over 30 minutes administered immediately after cyclophosphamide."

Trial Locations (1)

430000

RECRUITING

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan

All Listed Sponsors
collaborator

Nanjing IASO Biotechnology Co., Ltd.

INDUSTRY

lead

Tongji Hospital

OTHER