IASO206 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia

NCT07585071 | Not Yet Recruiting Phase 1

• 1 other identifier: IASO206CI003
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Relapsed/Refractory; Autoimmune Hemolytic Anemia

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of adverse events

  Assessed by CTCAE Version 5.0.

  Up to 3 months after IASO206 infusion

Secondary Outcomes (1)

• Proportion of patients achieving response

  At Weeks 4, 8, and 12, and Months 4, 5, and 6 after IASO206 infusion

Study Arms (1)

IASO206

EXPERIMENTAL

Subjects will receive a single infusion of IASO206 injection in a 3+3 dose-escalation design. Three ascending dose cohorts are planned: 1E8 TU, 3E8 TU, and 5E8 TU. In each dose cohort, the first subject will be observed for at least 3 weeks after infusion before subsequent subjects in the same cohort receive IASO206 injection.

Biological: IASO206 injection

Interventions

IASO206 injection BIOLOGICAL

The third-generation self-inactivating lentiviral vector that carries a BCMA-targeted CAR. Administered in one infusion.

IASO206

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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);

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune; Recurrence

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jun Shi, PhD

CONTACT

13752253515; shijun@ihcams.ac.cn

Lele Zhang, PhD

CONTACT

‭15811139278‬; zhanglele@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Red Blood Cell Diseases Center & Director of the Regenerative Medicine Clinic

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share