A Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia

Launched by CHINA IMMUNOTECH (BEIJING) BIOTECHNOLOGY CO., LTD. · Jul 11, 2025

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ClinConnect Summary

This clinical trial is testing a new treatment called YTS109 STAR-T cell therapy for people with a condition called autoimmune hemolytic anemia (AIHA). AIHA is a disease where the body’s immune system mistakenly attacks and destroys its own red blood cells, leading to anemia. This study is for patients whose AIHA has not improved after trying at least three different treatments. The main goal is to see if this new therapy is safe and how well it works in these patients. Researchers will also look at how the treatment behaves in the body and how it affects the immune system.

People aged 12 and older with AIHA or a related condition called Evans syndrome might be eligible if they have tried and not responded to several standard treatments. To join, participants need to be in generally good health aside from their anemia and must agree to follow the study’s rules, including using birth control if applicable. During the trial, participants will receive the YTS109 cells through one or more infusions, and doctors will carefully monitor their health and response to the therapy. It’s important to know that this is an early-stage study focused mainly on safety, so close follow-up will be part of the experience. Those with certain other health issues, infections, or recent treatments may not be eligible. Overall, this trial offers a chance to try a new approach for a challenging condition when other treatments have not worked.

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Eligibility criteria

• Inclusion Criteria:
• • 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%.
• • ECOG performance status≤2
• • Subjects of childbearing potential will be required to follow contraception requirements from the time of enrollment until the end of the 12-month safety follow-up period.
• • The subjects voluntarily participate in the study, sign the informed consent, demonstrate good compliance, and cooperate with follow-up.
• Exclusion Criteria:
• • 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
• • Receive any of the following treatments within the specified time before cell infusion: a.anti-CD20 monoclonal antibodies \<12 weeks, b.sutimlimab or other marketed biologics \<5 half-lives,c.plasma exchange \<4 weeks, d.post-splenectomy \<12 weeks, e. BTK inhibitors, anti-CD38 monoclonal antibody, Syk inhibitors, BAFF inhibitors \< 5 half-lives.
• • Previously received organ or stem cell transplantation
• • History of new thrombosis or organ infarction in the past 6 months
• • Diagnosis of the active stage of the connective tissue disease.
• • Have active infections, such as sepsis, bacteremia, fungemia, uncontrolled pulmonary infection and active tuberculosis, etc.
• • Positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab), and the HBV-DNA copy number is above the lower limit of the measurable capacity; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; positive syphilis test.
• • Underwent major surgery within 4 weeks before screening, as determined by the investigator to be unsuitable for enrollment.
• • Have malignant tumors within 5 years before enrollment, except tumors with negligible risk of metastasis or death and curable tumors, such as adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma, etc.
• • Have any of the following cardiovascular diseases: a.Left ventricular ejection fraction (LVEF) ≤45%, b. presence of active heart disease or congestive heart failure (New York Heart Association \[NYHA\] Class III or IV)), c.severe arrhythmias requiring treatment, d.have myocardial infarction, bypass surgery, or stent placement within the 6 months before the study, e.other heart diseases judged by the researcher to be unsuitable for enrollment.
• • Have a history of live attenuated vaccines within 6 weeks before enrollment.
• • Have a history of epilepsy or other active central nervous system diseases.
• • Have an allergy to the ingredients of the medicine used in this study.
• • Previously received CAR-T cell therapy.
• • Patients considered to be ineligible for the study by the investigator for reasons other than the above.