ClinicalTrials.gov record NCT07453836
Research on YTS109 Cell in Patients With Recurrent/Refractory Autoimmune Hemolytic Anemia
The Safety and Efficacy of YTS109 Cell for Relapsed/Refractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy.
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 1, single-arm study tests YTS109 STAR‑T cell therapy in people with autoimmune hemolytic anemia who have failed three or more prior treatments. The study starts with dose escalation (1×10^6 and 2×10^6 cells/kg) and may expand or raise the dose based on safety and early results. A second infusion is allowed in some patients after investigator assessment.
What it is studying. The study is evaluating the safety, tolerability, and preliminary efficacy of YTS109 STAR‑T cells, and measuring how the cells behave in the body (pharmacokinetics and pharmacodynamics). It will also track blood response measures and B‑cell recovery after infusion.
What the researchers hope to learn. To characterize safety and tolerability of YTS109 cell therapy; to measure treatment‑emergent adverse events and dose‑limiting toxicities; to assess early measures of hematologic response; and to evaluate pharmacokinetics, pharmacodynamics, and B‑cell reconstitution after infusion.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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. This study set up two dosage groups: 1e6 STAR+T cells/kg and 2e6 STAR+T cells/kg. With the starting dose of 1e6 STAR+T cells/kg, it was conducted according to the traditional 3+3 design rule. In this study, if the safety was good but the efficacy was not satisfactory at the dosage level of 2e6 STAR+T cells/kg, SRC could decide whether to continue increasing the dose to 3e6 STAR+T cells/kg based on the clinical preclinical data, cumulative safety, tolerance, preliminary efficacy, PK and other results. If the subject shows no response (NR) or experiences recurrence after remission, a second infusion may be administered-provided the patient voluntarily consents and the investigator, after comprehensive assessment, determines that the potential benefits outweigh the risks. The investigator may decide on the timing of re-infusion, the use of lymphodepleting pretreatment, and the dose and number of re-infusions based on prior safety, efficacy, and pharmacokinetic (PK) data.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- YTS109 cell
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 18 ≤ Age ≤ 60 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).
- Renal Function:
- Creatinine clearance (CrCl) ≥ 60 ml/minute (calculated using the Cockcroft-Gault formula).
- Oxygen Saturation (SpO₂): ≥ 92%.
- 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.
Exclusion criteria
- 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
- 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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive one or more infusions of YTS109 cells given at a study dose (the protocol starts at 1×10^6 or 2×10^6 cells/kg and may escalate). For a possible second infusion, the investigator may decide whether to use a lymphodepleting pretreatment. A second infusion is possible for participants who do not respond or who relapse, with timing and dose decided by the investigator. You will have regular clinic visits with blood samples to check safety, measure YTS109 levels and B cell counts, and investigators will monitor and record side effects over the weeks and months after infusion (including close monitoring in the first 28 days and follow-up measures up to about 12 months).
How the study is structured. Open-label, single-group Phase 1 study with a dose-escalation then dose-expansion plan. Enrollment begins with a 3+3 style dose-escalation at 1×10^6 cells/kg, then 2×10^6 cells/kg; the safety review committee may allow further escalation to 3×10^6 cells/kg based on accumulated safety and early activity data. Participants receive an infusion of YTS109 cells (no placebo or comparison arm). A second infusion may be given if a participant does not respond or relapses, with timing, use of lymphodepletion, and dose decided by the investigator. Safety and response are followed over weeks to months, and pharmacokinetic measures are collected up to about 12 months after infusion.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The registry says recruitment has not started. When is it expected to open, and can I register interest now?
- The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on autoimmune hemolytic anemia
Important dates
- Study start
- Mar 18, 2026 (estimated)
- Primary completion
- Mar 18, 2027 (estimated)
- Study completion
- Mar 18, 2028 (estimated)
- Target enrollment
- 13 participants (estimated)
- Last updated on registry
- Mar 6, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Liping Jing 📞 13820381160 ✉ jlp1160@126.com
Participating sites (1)
- Beijing GoBroad Boren Hospital
Beijing · China
- Liping Jing · 13820381160 · jlp1160@126.com
Terms used on this page · explanations by MedicalUpdates.ai
- single-arm
- All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- dose-escalation
- Groups of participants receive increasing doses of a treatment, one group after another, to find a dose that can be given safely.
- primary objective
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- pharmacokinetics
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- pharmacodynamics
- What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
- lines of therapy
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- glucocorticoids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- upper limit of normal
- The highest value of a blood test that a laboratory considers normal. Criteria such as '≤ 3 × ULN' mean the result must be no more than three times that value.
- Creatinine clearance
- A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
- ECOG performance status
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- safety follow-up
- The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
- informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- before screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- CAR-T
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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