This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD19 CAR-T therapy for patients with refractory myasthenia gravis, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
CD19 CAR-T in the Treatment of Refractory Myasthenia Gravis
The first affiliated hospital of medical college of zhejiang university
Hangzhou, Zhejiang, China
RECRUITINGDose-limiting toxicity (DLT)
Adverse events assessed according to NCI-CTCAE v5.0 criteria
Time frame: Baseline up to 28 days after CD19 CAR T-cells infusion
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Time frame: Up to 90 days after CD19 CAR T-cells infusion
Maximum tolerable dose
Maximum tolerable dose
Time frame: From date of initial treatment to Day 28 post CD19 CAR-T infusion.
Changes in serum AchR antibody titer
Changes in serum AchR antibody titer
Time frame: days 7, 14, 21, 28 and 90
MG-activities of daily living profile (MG-ADL)
MG-ADL Myasthenia Gravis Daily Activity Scale
Time frame: Baseline up to 28 days after CD19 CAR T-cells infusion
MG-activities of daily living profile (QMG)
Quantitative Score for Myasthenia Gravis
Time frame: Baseline up to 28 days after CD19 CAR T-cells infusion
Myasthenia Gravis Composite Scale (MGC)
Myasthenia Gravis Composite Scale
Time frame: Baseline up to 28 days after CD19 CAR T-cells infusion
MG-QOL15 scale
MG-QOL15 Quality of Life Scale for Myasthenia Gravis (15 items)
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Time frame: Baseline up to 28 days after CD19 CAR T-cells infusion