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Autoimmune Hemolytic AnemiaPhase 1NCT07585071

IASO206 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia

A Phase 1 study testing IASO206 injection in people with Autoimmune Hemolytic Anemia and Relapsed/Refractory, run by Institute of Hematology & Blood Diseases Hospital, China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
IASO206 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
No sites listed yet
Study dates
15 Jun 2026to 31 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 33Show fewer
  • 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.
  • Subject with uncontrolled active fungal, viral, bacterial, mycobacterial, or other infections (persistent infection-related signs/symptoms without improvement after appropriate anti-infective therapy) or infections requiring intravenous anti-infective therapy.
  • Positive hepatitis B surface antigen (HBs-Ag) or hepatitis B e antigen (HBe-Ag); positive hepatitis B e antibody (HBe-Ab) or hepatitis B core antibody (HBc-Ab) with HBV-DNA copy number above the lower limit of quantification; positive hepatitis C (HCV) antibody; positive human immunodeficiency virus (HIV) antibody; active syphilis infection (excluding those with only positive syphilis-specific antibody).
  • Subject who received live viral vaccines within 4 weeks before enrollment.
  • Subject who are participating in other interventional clinical studies during IASO206 Injection treatment with a drug half-life < 5; subject receiving active investigational drugs during the entire study period, or who intend to participate in another clinical trial, or receive treatments outside the protocol.
  • Pregnant or lactating females.
  • Subject with psychiatric disorders, disturbance of consciousness, or central nervous system diseases, including but not limited to epilepsy and Parkinson's disease.
  • Subject with hypersensitivity to components of IASO206 Injection or supportive medications required for the management of CAR-T therapy-related toxicities (e.g., tocilizumab).
  • Other conditions judged by the investigator to be unsuitable for enrollment.10. Other Information

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jun Shi, PhD contact

13752253515

shijun@ihcams.ac.cn

Lele Zhang, PhD contact

‭15811139278‬

zhanglele@ihcams.ac.cn

About this study

Official title: Phase I Clinical Study on the Safety and Tolerability of IASO206 Injection in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia

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

Being tested
IASO206 injection
Medical subject headings
Anemia, Hemolytic, Autoimmune, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IASO206 injectionBiological

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

Study groups in NCT07585071
Study groupRoleWhat they receive
IASO206ExperimentalSubjects 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.
Receives: Biological: IASO206 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events

    Assessed by CTCAE Version 5.0.

    Measured: Up to 3 months after IASO206 infusion

Secondary outcomes (1)

  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2026
  2. Study start15 Jun 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07585071
Sponsor's protocol ID
IASO206CI003
Status last verified
May 2026
First submitted
6 May 2026
Last updated
13 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IASO206 injection in people with Autoimmune Hemolytic Anemia and Relapsed/Refractory, run by Institute of Hematology & Blood Diseases Hospital, China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jun Shi, PhD (13752253515, shijun@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (time frame: Up to 3 months after IASO206 infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07585071.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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