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Autoimmune Hemolytic AnemiaPhase 1NCT07287930

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

A Phase 1 study testing YTS109 cell in people with Autoimmune Hemolytic Anemia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

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
Search all trials

Trial summary

This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The primary objective is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of YTS109 STAR-T cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Autoimmune Hemolytic Anemia
What is being tested?
YTS109 cell
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
No sites listed yet
Study dates
25 Dec 2025to 26 Dec 2027
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years, regardless of gender.
  • A definitive diagnosis of Autoimmune Hemolytic Anemia (AIHA) or Evans Syndrome [including warm antibody-type, mixed warm-cold antibody-type, and cold antibody-type hemolytic anemia (cold agglutinin disease)] has been established, with diagnostic criteria referenced from the Chinese Clinical Practice Guidelines for the Diagnosis and Treatment of Autoimmune Hemolytic Anemia in Adults (2023 Edition).
  • Patients who have undergone at least three failed treatment attempts, whose anemia symptoms (hemoglobin < 100 g/L) persist despite conventional therapy, and who remain unresponsive or experience recurrence after disease remission. Definition of Conventional Therapy: Treatment with glucocorticoids and/or rituximab, combined with any one or more of the following interventions: splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, bendamustine, fludarabine, bortezomib, or other pharmacological agents, as well as biologic agents including anti-CD38 monoclonal antibodies, BTK inhibitors, Syk inhibitors, complement inhibitors, etc.
  • Adequate Organ Function:
  • Liver Function:
  • Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN); Total bilirubin ≤ 2.0 × ULN (excluding Gilbert syndrome, where total bilirubin ≤ 3.0 × ULN).
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  • Renal Function:
  • Creatinine clearance (CrCl) ≥ 60 ml/minute (calculated using the Cockcroft-Gault formula).
  • Oxygen Saturation (SpO₂): ≥ 92%.
  • Bone Marrow Function Requirements:
  • Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L;
  • Platelet count ≥ 30 × 10⁹/L;
  • International normalized ratio (INR) ≤ 1.5 × ULN;
  • Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
  • 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.

Who cannot join

  • • 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
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  • 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.

Trial locations and contacts

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

Heng Mei Professor Heng Mei contact

+86 13886180811

hmei@hust.cdu.cn

About this study

Official title: The Safety and Efficacy of YTS109 Cell for Relapsed/Refractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy.

This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. The primary objective is to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of YTS109 STAR-T cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy. The objective is to evaluate the safety, preliminary efficacy, pharmacokinetics/pharmacodynamics (PK/PD), and immune cell reconstitution characteristics of YTS109 cell therapy in Multi-rAIHA subjects who have failed third-line or higher-line treatments.

This study will also conduct an exploratory investigation into the impact of non-lymphodepleting conditioning prior to the infusion of STAR-T cells. For the non-lymphodepleting exploratory cell infusion, it can be administered as a single infusion or divided into 1 to 3 infusions (with the fractionated infusions to be completed within 7 days (and in any case no later than 15 days)). Dose escalation will commence at 1E6 cells/kg or the starting dose may be adjusted based on accumulated data.

Read the detailed description

Not provided

Being tested
YTS109 cell
Medical subject headings
Anemia, Hemolytic, Autoimmune

What participants receive

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

  • YTS109 cellDrug

    Subjects will receive YTS109 cell, and dose escalation will commence at 1E6 cells/kg or the starting dose may be adjusted based on accumulated data.

Study groups in NCT07287930
Study groupRoleWhat they receive
Experimental: YTS109 cellExperimentalSubjects will receive YTS109 cell, and dose escalation will commence at 1E6 cells/kg or the starting dose may be adjusted based on accumulated data.
Receives: Drug: YTS109 cell

What is being measured

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

  1. • Dose Limiting Toxicity [Time Frame: Within 28 days after infusion]

    Safety assessments are conducted using the NCI-CTCAE version 5.0 standards.

    Measured: Within 28 days

  2. • The incidence and frequency of treatment-emergent adverse events [Time Frame: Within 6 months after infusion]

    Safety assessments are conducted using the NCI-CTCAE version 5.0 standards.

    Measured: Within 6 months

Secondary outcomes (7)

  1. • Best overall response rate (BOR) of each dose group [Time Frame: Within 12 weeks after infusion]

    BOR is determined as the most favorable response observed after cell infusion, until either disease relapse or the completion of a specified observation

    Measured: Within 12 weeks

  2. • Objective response rate (ORR) of each dose group [Time Frame: Within 4 weeks after infusion]

    Measured: Within 4 weeks

  3. • Time to response (TTR) [Time Frame: Within 6 months after infusion]

    TTR is defined as the duration from cell infusion to the achievement of a hematological response

    Measured: Within 6 months

  4. • Peak Plasma Concentration (Cmax) of YTS109 To evaluate the metabolic characteristics of YTS109

    Measured: Within 12 months after infusion

  5. • Time to Peak (Tmax) of YTS109 To evaluate the metabolic characteristics of YTS109

    Measured: Within 12 months after infusion.

  6. • Area under the plasma concentration versus time curve (AUC) of YTS109 To evaluate the metabolic characteristics of YTS109

    Measured: Within 12 months after infusion.

  7. • The reconstitution of B cell in peripheral blood Changes in B cells quantification and phenotypic in peripheral blood

    Measured: Within 12 months after infusion.

Timeline

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

  1. First posted17 Dec 2025
  2. Study start25 Dec 2025 (estimated)
  3. Primary completion25 Dec 2026 (estimated)
  4. Study completion26 Dec 2027 (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
13 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07287930
Sponsor's protocol ID
YTS109-011
Status last verified
Dec 2025
First submitted
4 Dec 2025
Last updated
17 Dec 2025
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 YTS109 cell in people with Autoimmune Hemolytic Anemia, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology.

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 17 inclusion and 18 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 17 Dec 2025. 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 Heng Mei Professor Heng Mei (+86 13886180811, hmei@hust.cdu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

• Dose Limiting Toxicity [Time Frame: Within 28 days after infusion] (time frame: Within 28 days). The study lists 2 primary outcomes in all. 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 NCT07287930.

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 17 Dec 2025.

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