This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in AIHA who have failed ≥ 3 lines of therapy
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in autoimmune hemolytic anemia who have failed ≥ 3 lines of therapy. Study intervention consists of a single infusion of universal allogeneic CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide. Interim analysis will be performed when participants finish the visit 12 weeks after CAR T-cell infusion.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells.
The Second Hospital of Anhui Medical University
Hefei, China
RECRUITINGIncidence of Dose-Limiting Toxicities (DLTs)
The number, frequency, and severity of DLTs experienced by subjects after the first infusion of QT-219C. DLTs are defined by NCI-CTCAE 5.0 and ASTCT consensus for CRS and neurotoxicity
Time frame: Day 0 to Day 28 post-infusion
Incidence of Adverse Events (AEs)
Evaluation of the number, frequency, and severity of all adverse events, including Treatment-Emergent Adverse Events (TEAEs), Treatment-Related Adverse Events (TRAEs), and Serious Adverse Events (SAEs).
Time frame: Up to 12 Months After UCAR T-cell Infusion
Clinical response of AIHA who have failed ≥ 3 lines of therapy
Rates of CR, CRi, PR, ORR
Time frame: Up to 24 Weeks After UCAR T-cell Infusion
Cmax of CAR-T cells [PK parameter]
The peak plasma concentration (Cmax) of amplified UCAR-T cells in peripheral blood after infusion
Time frame: Within 28 Days After UCAR T-cell Infusion
Tmax of CAR-T cells [PK parameter]
The time of amplified UCAR-T cells in peripheral blood to reach the maximum concentration (Tmax).
Time frame: Within 28 Days After UCAR T-cell Infusion
AUC 0-28d of UCAR-T cells [PK parameter]
The area under the plasma concentration-time curve from 0 to 28 days after infusion (AUC0-28d)
Time frame: Within 28 Days After UCAR T-cell Infusion
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