To Evaluate the Safety and Efficacy of ThisCART19A for Relapsed/Refractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy
This is a phase 1, single-arm, open-label, dose-escalation and dose-expansion study. The main purpose is to evaluate the safety and tolerability, efficacy, pharmacokinetics and pharmacodynamics of ThisCART19A in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy, which include glucocorticoids, rituximab, cyclophosphamide, azathioprine, fludarabine, cyclosporine, mycophenolate mofetil, BTK inhibitors, splenectomy, etc. Participants will receive ThisCART19A cell infusion after preconditioning, and they need to be closely monitored for 28 days following CAR-T cell infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Participants will receive ThisCART19A cell infusion after preconditioning, and they need to be closely monitored for 28 days following CAR-T cell infusion.
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China
RECRUITINGThe incidence and frequency of treatment-emergent adverse events
Time frame: Within 6 months
Maximal Tolerable Dose(MTD)
MTD is classified by the NCI CTCAE V5.0
Time frame: Up to 28 days after infusion
Best response rate (BOR) of each dose group
BOR is determined as the most favorable response observed after cell infusion, until either disease relapse or the completion of a specified observation period.
Time frame: Within 12 weeks after infusion
Objective response rate (ORR)
Percentage of patients with hematological response
Time frame: Within 4 weeks after infusion
Time to response (TTR)
TTR is defined as the duration from cell infusion to the achievement of a hematological response
Time frame: Within 6 months
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