IASO206 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInstitute of Hematology & Blood Diseases Hospital, China
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
IASO206 injection
Biological/VaccineThe third-generation self-inactivating lentiviral vector that carries a BCMA-targeted CAR. Administered in one infusion.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: IASO206Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events
Assessed by CTCAE Version 5.0.
Time frame
Up to 3 months after IASO206 infusionSecondary outcomes
1
Proportion of patients achieving response
Response assessment is primarily assessed based on hemoglobin, and should be performed after discontinuation of glucocorticoids or other immunosuppressive therapies for at least 2 weeks.
Time frame
At Weeks 4, 8, and 12, and Months 4, 5, and 6 after IASO206 infusionLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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