IASO206 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia

Starting soon · Phase 1

Conditions studied: Autoimmune Hemolytic Anemia, Relapsed/Refractory

In brief

This study is an open-label, single-arm early exploratory clinical study, aiming to evaluate the safety, tolerability and preliminary efficacy of IASO206 Injection (In Vivo CAR-T) in Patients with Relapsed/Refractory Autoimmune Hemolytic Anemia

Key facts

Study ID

NCT07585071

Run by

Institute of Hematology & Blood Diseases Hospital, China

People needed

18

Starts

2026-06-15

Expected to finish

2028-12-31

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18 to 75 years, gender unrestricted.
• Diagnosis of AIHA (including warm antibody type, warm-cold antibody type, cold agglutinin disease) or Evans syndrome, consistent with Chinese Expert Consensus on Diagnosis and Treatment of Autoimmune Hemolytic Anemia (2023), 2019 International Consensus for Diagnosis and Management of Autoimmune Hemolytic Anemia (Blood Rev, 2020), or Chinese Expert Consensus on Diagnosis and Treatment of Evans Syndrome (2024 Edition).
• Patients with relapsed/refractory disease after multiple lines of therapy must meet all of the following criteria: hemoglobin < 10 g/dL with clinical manifestations of hemolytic anemia; prior treatment with at least 2 immunosuppressive drugs (must include CD20 monoclonal antibody); glucocorticoid therapy for at least 3 months (excluded are patients with contraindications to glucocorticoids, severe infection, severe osteoporosis, previous fracture, or inability to tolerate glucocorticoids); cumulative dose of CD20 monoclonal antibody at least 375 mg/m² × 4, or total dose 2.0 g, or at least 6 administrations (at least 1 week apart each time).
• ECOG score ≤ 2.
• Expected survival time ≥ 12 weeks.
• Adequate organ function confirmed by laboratory tests: serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × upper limit of normal (ULN); minimum pulmonary reserve defined as grade ≤ 1 dyspnea and oxygen saturation ≥ 93% without oxygen supplementation; creatinine clearance (estimated by Cockcroft-Gault) ≥ 45 mL/min; cardiac ejection fraction ≥ 50%, no pericardial effusion on echocardiogram (ECHO), and no clinically significant abnormal electrocardiogram (ECG).
• Subjects and their partners agree to use effective barrier or medical contraceptive measures (excluding rhythm method) from signing informed consent until 1 year after administration.
• Subjects must provide written informed consent approved by the Ethics Committee prior to initiation of screening procedures

You may not qualify if…

• Subject with confirmed lymphoproliferative neoplasms.
• Subject with secondary AIHA induced by drugs or infection.
• Subject with congenital immunodeficiency diseases, other hereditary or acquired hemolytic diseases.
• Subject with a history of organ or stem cell transplantation.
• Subject with a history of organ infarction within the past 6 months.
• Subject who have received prior BCMA-targeted therapy.
• Subject who received plasma cell-targeted cell therapy within 3 months before screening, or in whom prior cell therapy products are still detectable in peripheral blood.
• Subject who received any of the following treatments within the specified periods prior to study enrollment:
• Anti-CD20 monoclonal antibody < 12 weeks;
• Sutimlimab or other marketed biological products < 5 half-lives;
• Plasma exchange < 4 weeks;
• Splenectomy < 12 weeks.
• Subject with any of the following cardiovascular diseases:
• Left ventricular ejection fraction (LVEF) ≤ 45%;
• Active heart disease or congestive heart failure (New York Heart Association [NYHA] Class III or IV);
• Severe arrhythmia requiring treatment (excluding atrial fibrillation, paroxysmal supraventricular tachycardia);
• QTcB interval ≥ 450 ms for males, ≥ 470 ms for females;
• Myocardial infarction, bypass surgery, or stent implantation within 6 months before study;
• Other cardiac diseases judged by the investigator to be unsuitable for enrollment.
• Unstable systemic diseases judged by the investigator, including but not limited to severe hepatic or renal diseases requiring medical treatment.
• Subject with a history of other primary malignancies within 5 years before screening, except:
• Resected and cured non-melanoma skin cancer (e.g., basal cell carcinoma);
• Cured carcinoma in situ (e.g., cervical, bladder, or breast cancer);
• Other primary cancers with no evidence of recurrence for more than 5 years after treatment.
• Subject who underwent major surgery within 4 weeks before screening and are judged unsuitable for enrollment by the investigator.

Full record on ClinicalTrials.gov

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