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 STAR-T cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy. The objective is to evaluate the safety, preliminary efficacy, pharmacokinetics/pharmacodynamics (PK/PD), and immune cell reconstitution characteristics of YTS109 cell therapy in Multi-rAIHA subjects who have failed third-line or higher-line treatments.
This study will also conduct an exploratory investigation into the impact of non-lymphodepleting conditioning prior to the infusion of STAR-T cells. For the non-lymphodepleting exploratory cell infusion, it can be administered as a single infusion or divided into 1 to 3 infusions (with the fractionated infusions to be completed within 7 days (and in any case no later than 15 days)). Dose escalation will commence at 1E6 cells/kg or the starting dose may be adjusted based on accumulated data.
Age ≥18 years, regardless of gender.
A definitive diagnosis of Autoimmune Hemolytic Anemia (AIHA) or Evans Syndrome [including warm antibody-type, mixed warm-cold antibody-type, and cold antibody-type hemolytic anemia (cold agglutinin disease)] has been established, with diagnostic criteria referenced from the Chinese Clinical Practice Guidelines for the Diagnosis and Treatment of Autoimmune Hemolytic Anemia in Adults (2023 Edition).
Patients who have undergone at least three failed treatment attempts, whose anemia symptoms (hemoglobin < 100 g/L) persist despite conventional therapy, and who remain unresponsive or experience recurrence after disease remission. Definition of Conventional Therapy: Treatment with glucocorticoids and/or rituximab, combined with any one or more of the following interventions: splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, bendamustine, fludarabine, bortezomib, or other pharmacological agents, as well as biologic agents including anti-CD38 monoclonal antibodies, BTK inhibitors, Syk inhibitors, complement inhibitors, etc.
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 cell
DrugSubjects will receive YTS109 cell, and dose escalation will commence at 1E6 cells/kg or the starting dose may be adjusted based on accumulated data.
• Dose Limiting Toxicity [Time Frame: Within 28 days after infusion]
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards.
• The incidence and frequency of treatment-emergent adverse events [Time Frame: Within 6 months after infusion]
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards.
• Best overall response rate (BOR) of each dose group [Time Frame: Within 12 weeks after infusion]
BOR is determined as the most favorable response observed after cell infusion, until either disease relapse or the completion of a specified observation
• Objective response rate (ORR) of each dose group [Time Frame: Within 4 weeks after infusion]
• Time to response (TTR) [Time Frame: Within 6 months after infusion]
TTR is defined as the duration from cell infusion to the achievement of a hematological response
• Peak Plasma Concentration (Cmax) of YTS109 To evaluate the metabolic characteristics of YTS109
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
China Immunotech (Beijing) Biotechnology Co., Ltd.
Collaborator
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