This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The primary objective is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of YTS109 START T-cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy.
Age ≥12 years, regardless of gender.
Diagnosis of AIHA or Evans syndrome [including warm antibody, mixed AIHA and cold antibody AIHA (Cold agglutinin disease)].
Failure or intolerance to at least 3 lines of therapy: glucocorticoids and/or rituximab, and any one of the following treatments (splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, bendamustine, fludarabine, bortezomib, etc.Biologics, including anti-CD38 monoclonal antibody, BTK inhibitor, Syk inhibitor and complement inhibitor) (HGB < 100g/L).
Adequate organ function: a. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN. b. Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥60ml/min. c.Blood oxygen saturation (SpO2) ≥92%.
Diagnosis of lymphoproliferative tumor
Other hereditary or acquired hemolytic diseases (Secondary AIHA caused by drugs or infection)
The platelet count in peripheral blood<30×10^9/L
Pregnant or breast-feeding subjects
Single group
YTS109
Biological/VaccineIn this study, subjects will receive YTS109 Cell Injection(0.5-1E6 STAR+T cell/kg) once.
Dose Limiting Toxicity
The incidence and frequency of treatment-emergent adverse events
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards.
Best overall 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.
Objective response rate (ORR) of each dose group
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Institute of Hematology & Blood Diseases Hospital, China
Lead sponsor
China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
