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

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called YTS109 STAR T-cell therapy for patients with a condition known as autoimmune hemolytic anemia (AIHA). This study is specifically for individuals who have not responded well to at least three previous treatments for their condition. The aim is to see how safe this therapy is, how well it works, and how it affects the body. The trial is open to people aged 12 and older, regardless of gender, who have AIHA or Evans syndrome and meet certain health criteria.

Participants in this trial can expect to receive the YTS109 treatment and will be monitored closely for any side effects and its effectiveness. To be eligible, they must have had difficulties with multiple other treatments and must not have certain other health conditions, such as active infections or heart diseases. It’s important for potential participants to understand that they need to give informed consent and be willing to follow up for safety assessments after the treatment. This trial is not yet recruiting, so there's no need to apply just yet, but it could be a promising option for those struggling with this challenging condition in the future.

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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.