Autoimmune Hemolytic AnemiaPhase 1NCT06770504
A Study of YTS109 Cell Injection in Subjects With Relapsed/Refractory Autoimmune Hemolytic Anemia
A Phase 1 study testing YTS109 in people with Autoimmune Hemolytic Anemia and Anti-CD19 STAR T-cell Therapy, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 START 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 12 years and older
- Conditions the study is for
- Autoimmune Hemolytic Anemia, Anti-CD19 STAR T-cell Therapy, Failure ≥3 Lines of Therapies
- What is being tested?
- YTS109
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 26 Feb 2025to 30 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥12 years, regardless of gender.
- Diagnosis of AIHA or Evans syndrome [including warm antibody, mixed AIHA and cold antibody AIHA (Cold agglutinin disease)].
- Failure or intolerance to at least 3 lines of therapy: glucocorticoids and/or rituximab, and any one of the following treatments (splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, bendamustine, fludarabine, bortezomib, etc.Biologics, including anti-CD38 monoclonal antibody, BTK inhibitor, Syk inhibitor and complement inhibitor) (HGB < 100g/L).
- Adequate organ function: a. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN. b. Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥60ml/min. c.Blood 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.
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
1 site in 1 country.
About this study
Official title: The Safety and Efficacy of YTS109 Cell Injection 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 START T-cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy.
- Being tested
- YTS109
- Keywords
- Relapsed/Refractory Autoimmune Hemolytic Anemia, CD19-STAR T cells
- 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.
YTS109Biological
In this study, subjects will receive YTS109 Cell Injection(0.5-1E6 STAR+T cell/kg) once.
| Study group | Role | What they receive |
|---|---|---|
| YTS109 | Experimental | Participants will receive YTS109 cell infusion after preconditioning, and they need to be closely monitored for 24 hours following START-T cell infusion. Receives: Biological: YTS109 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Measured: Within 28 days after infusion
The incidence and frequency of treatment-emergent adverse events
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards.
Measured: Within 12 months after infusion
Best overall response rate (BOR) of each dose group
BOR is determined as the most favorable response observed after cell infusion, until either disease relapse or the completion of a specified observation period.
Measured: Within 12 weeks after infusion
Objective response rate (ORR) of each dose group
Measured: Within 4 weeks after infusion
Time to response (TTR)
TTR is defined as the duration from cell infusion to the achievement of a hematological response
Measured: Within 6 months after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start26 Feb 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 7 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Jun Shi, Institute of Hematology & Blood Diseases Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770504
- Sponsor's protocol ID
- IIT2024106
- Status last verified
- Nov 2026
- First submitted
- 7 Jan 2025
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of YTS109 Cell Injection for Relapsed/Refractory Autoimmune Hemolytic Anemia Patients After Receiving Three or More Lines of Therapy.
- ClinicalTrials.gov ID
- NCT06770504
- Acronym / sponsor ID
- IIT2024106
- Keywords
- Relapsed/Refractory Autoimmune Hemolytic Anemia, CD19-STAR T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 START T-cell therapy in patients with autoimmune hemolytic anemia who have failed ≥3 lines of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| YTS109 | Experimental | Biological: YTS109Participants will receive YTS109 cell infusion after preconditioning, and they need to be closely monitored for 24 hours following START-T cell infusion. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥12 years, regardless of gender.
- Diagnosis of AIHA or Evans syndrome [including warm antibody, mixed AIHA and cold antibody AIHA (Cold agglutinin disease)].
- Failure or intolerance to at least 3 lines of therapy: glucocorticoids and/or rituximab, and any one of the following treatments (splenectomy, cyclosporine, cyclophosphamide, azathioprine, mycophenolate mofetil, bendamustine, fludarabine, bortezomib, etc.Biologics, including anti-CD38 monoclonal antibody, BTK inhibitor, Syk inhibitor and complement inhibitor) (HGB < 100g/L).
- Adequate organ function: a. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN. b. Creatinine clearance (CrCl) (Cockcroft-Gault formula) ≥60ml/min. c.Blood oxygen saturation (SpO2) ≥92%.
- ECOG performance status≤2
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YTS109In this study, subjects will receive YTS109 Cell Injection(0.5-1E6 STAR+T cell/kg) once. | Biological | YTS109 |
Primary outcome
Dose Limiting Toxicity
Time frame: Within 28 days after infusion
The incidence and frequency of treatment-emergent adverse events
Time frame: Within 12 months after infusion
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards.
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 period.
Objective response rate (ORR) of each dose group
Time frame: Within 4 weeks after infusion
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing YTS109 in people with Autoimmune Hemolytic Anemia and Anti-CD19 STAR T-cell Therapy, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in 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 7 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: Within 28 days after infusion). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.