Immune ThrombocytopeniaPhase 1NCT07599280
Universal STAR-T Cell Injection in R/R Autoimmune Diseases.
A Phase 1 study testing Universal STAR-T Cell in people with Immune Thrombocytopenia, run by Jian Zhu at 1 site in China.
Trial summary
This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study. This study evaluates the safety and efficacy of universal STAR-T cells in patients with R/R CTD-associated Immune Thrombocytopenia (CTD-ITP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Immune Thrombocytopenia
- What is being tested?
- Universal STAR-T Cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2026to 11 May 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ranges from 18 to 65 years old (including threshold), regardless of gender.
- Confirmed diagnosis of a connective tissue disease (CTD) according to the latest international classification criteria, including but not limited to Systemic Lupus Erythematosus (SLE), Primary Sjögren's Syndrome (pSS), Antiphospholipid Syndrome (APS), and Undifferentiated Connective Tissue Disease (UCTD).
- Confirmed diagnosis of CTD-associated immune thrombocytopenia meeting one of the following:
- Platelet count < 30 × 10⁹/L; Platelet count < 50 × 10⁹/L accompanied by bleeding tendency.
- Bone marrow morphology consistent with the characteristics of immune thrombocytopenia (ITP).
- Prior Treatment History: Failure to achieve partial remission (PR) after receiving at least one of the following regimens continuously for ≥ 3 months, or inability to maintain efficacy during glucocorticoid tapering:
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- At least one course of glucocorticoid pulse therapy; Or high-dose glucocorticoids combined with one or more immunosuppressants (including biologics).
- 6. Essential Organ Function Criteria:
- Bone marrow: Neutrophils ≥1×10^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use).
- Hemoglobin ≥60 g/L.
- Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL
- ≤1.5×ULN (disease-related elevations permitted).
- Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).
- Coagulation: INR/PT ≤1.5×ULN.
- Cardiovascular: Hemodynamic stability. 7. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.
- 8. Voluntary participation with signed informed consent and compliance.
Who cannot join
- Subjects who meet any of the following exclusion criteria will not be admitted to the study:
- Individuals with a severe history of drug allergies or those with an allergic constitution;
- Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;
- Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);
- Subjects whose cardiac function cannot tolerate the study interventions;
- Subjects with congenital immunoglobulin deficiencies;
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- Subjects with a history of malignant tumors within the past five years;
- Subjects with end-stage renal failure;
- Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;
- Subjects with psychiatric disorders or severe cognitive dysfunction;
- Subjects who have participated in other clinical trials within the past three months prior to enrollment;
- Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;
- Pregnant women or women planning to become pregnant;
- Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
No. 28, Fuxing Road, Haidian District, Beijing, China.
Haidian, Beijing Municipality
About this study
Official title: An Exploratory Clinical Study of Universal STAR-T Cell Injection in Subjects With Relapsed/Refractory Autoimmune Diseases
This is a Phase I, single-arm, open-label, dose-escalation and dose-expansion study.
This study evaluates the safety and efficacy of universal STAR-T cells in patients with R/R CTD-associated Immune Thrombocytopenia (CTD-ITP). Approximately 9 patients aged 18-65 will receive infusion of universal STAR-T cells at the starting dose of 3E6 STAR+T cells/kg. The main purpose of exploratory clinical research is to explore the efficacy and safety of universal STAR-T cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.
Read the detailed description
Background: Connective Tissue Disease-associated Immune Thrombocytopenia (CTD-ITP) is a severe complication of autoimmune disorders, including Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (pSS), and Antiphospholipid Syndrome (APS). Thrombocytopenia occurs in 20%-40% of SLE patients and up to 50% of APS patients. While often mild, severe cases lead to significant bleeding risk, poor quality of life, and increased mortality.
Current standard therapies-glucocorticoids, intravenous immunoglobulin (IVIG), and immunosuppressants (e.g., cyclophosphamide, mycophenolate mofetil)-often fail in refractory or relapsing cases. Long-term dependence on high-dose steroids results in severe adverse events (infections, osteoporosis) and poor prognosis.
B cells play a central role in autoantibody production and immune dysregulation in CTD-ITP. Novel strategies focusing on deep B-cell depletion or immune reconstitution offer a promising new approach for patients who have exhausted conventional treatments.
This study aims to evaluate the safety and preliminary efficacy of universal STAR-T cell in patients with relapsed/refractory CTD-ITP. Approximately 3~6 patients aged 18-65 will be enrolled in the dose-escalation phase to receive infusion of universal STAR-T cells at the starting dose of 3E6 STAR+T cells/kg.
In patients with relapsed/refractory connective tissue disease-associated immune thrombocytopenia, the primary efficacy endpoint is the complete response rate at week 12, while the secondary efficacy endpoints include the complete response rate at week 24; the partial response rate, overall response rate, and change in platelet count from baseline at both weeks 12 and 24; as well as time to response, drug-free remission duration, and response duration.
Study endpoints include primary endpoints such as dose - limiting toxicity (DLT), the type, severity, and frequency of adverse events (AE), and efficacy endpoints; secondary endpoints encompass the in - vivo expansion and persistence of universal STAR - T cells, main pharmacokinetic (PK) parameters (including peak expansion (Cₘₐₓ), time to peak (Tₘₐₓ), area under the blood concentration - time curve (AUC), and studies on cell subtypes and dominant clones), main pharmacodynamic (PD) parameters (such as changes in cytokines and the level and characteristics of immune cell reconstitution like CD19 - positive B cells), and immunogenicity - related studies (including the production of anti - drug antibodies (ADA) against universal STAR - T cells and replication - competent associated virus (RCA) in peripheral blood).
- Conditions
- Immune Thrombocytopenia
- Being tested
- Universal STAR-T Cell
- Keywords
- CTD, Relapsed Refractory, Autoimmune
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal STAR-T CellDrug
Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 3E6 STAR+T cells/kg.
| Study group | Role | What they receive |
|---|---|---|
| Universal STAR-T Cell | Experimental | Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 3E6 STAR+T cells/kg. Receives: Drug: Universal STAR-T Cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs).
To assess the safety and tolerability of [Drug Name] and determine the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D). DLTs are defined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: Within 28 days after infusion
Secondary outcomes (9)
Preliminary assessment of efficacy.
- Evaluation of preliminary efficacy based on relevant disease activity indices or response criteria.
Measured: The efficacy endpoint evaluation for 104 weeks.
Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Serious Adverse Events (SAEs). Description: Characterization of treatment-emergent adverse events (TEAEs) graded by NCI-CTCAE v5.0, including laboratory abnormalities, vital sign changes, and infusion-related reactions.
Measured: AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks.
Maximum Plasma Concentration of YTS109 (Cmax) .
To evaluate the maximum observed plasma concentration of YTS109.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Time to Reach Maximum Plasma Concentration (Tmax) of YTS109
To evaluate the time to reach the maximum observed plasma concentration of YTS109
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Area Under the Plasma Concentration-Time Curve (AUC) of YTS109
To evaluate the total systemic exposure to YTS109 over time.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
PD Biomarker Level Change (Cytokines Concentration).
Evaluate the Pharmacodynamic (PD) effects of YTS109 cells.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
PD Biomarker Level Change (B cells Quantification and Phenotypic).
Evaluate the Pharmacodynamic (PD) effects of YTS109 cells.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Immunogenicity: Anti-Drug Antibodies (ADA) against universal STAR-T cells
To evaluate the development of anti-drug antibodies (ADA) against allogeneic universal STAR-T cells in peripheral blood.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Replication-Competent Adeno-Associated Virus (RCA) Detection
To evaluate the presence of replication-competent adeno-associated virus (RCA) in peripheral blood.
Measured: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start11 May 2026 (estimated)
- Primary completion11 May 2027 (estimated)
- Study completion11 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies of the same condition, open and under way.
- 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
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jian Zhu
- Sponsor type
- University, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Responsible party
- Sponsor-investigator, Jian Zhu, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599280
- Sponsor's protocol ID
- YTS109-006
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 20 May 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of Universal STAR-T Cell Injection in Subjects With Relapsed/Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07599280
- Acronym / sponsor ID
- YTS109-006
- Conditions
- Immune Thrombocytopenia
- Keywords
- CTD, Relapsed Refractory, Autoimmune
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Jian ZhuUniversity, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Study start
- 11 May 2026 (estimated)
- Primary completion
- 11 May 2027 (estimated)
- Study completion
- 11 May 2028 (estimated)
- First posted
- 20 May 2026 (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.
This study evaluates the safety and efficacy of universal STAR-T cells in patients with R/R CTD-associated Immune Thrombocytopenia (CTD-ITP). Approximately 9 patients aged 18-65 will receive infusion of universal STAR-T cells at the starting dose of 3E6 STAR+T cells/kg. The main purpose of exploratory clinical research is to explore the efficacy and safety of universal STAR-T cell and the lymphodepletion regimen. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Chinese People's Liberation Army (PLA) General Hospital.
Detailed description
Background: Connective Tissue Disease-associated Immune Thrombocytopenia (CTD-ITP) is a severe complication of autoimmune disorders, including Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (pSS), and Antiphospholipid Syndrome (APS). Thrombocytopenia occurs in 20%-40% of SLE patients and up to 50% of APS patients. While often mild, severe cases lead to significant bleeding risk, poor quality of life, and increased mortality.
Current standard therapies-glucocorticoids, intravenous immunoglobulin (IVIG), and immunosuppressants (e.g., cyclophosphamide, mycophenolate mofetil)-often fail in refractory or relapsing cases. Long-term dependence on high-dose steroids results in severe adverse events (infections, osteoporosis) and poor prognosis.
B cells play a central role in autoantibody production and immune dysregulation in CTD-ITP. Novel strategies focusing on deep B-cell depletion or immune reconstitution offer a promising new approach for patients who have exhausted conventional treatments.
This study aims to evaluate the safety and preliminary efficacy of universal STAR-T cell in patients with relapsed/refractory CTD-ITP. Approximately 3~6 patients aged 18-65 will be enrolled in the dose-escalation phase to receive infusion of universal STAR-T cells at the starting dose of 3E6 STAR+T cells/kg.
In patients with relapsed/refractory connective tissue disease-associated immune thrombocytopenia, the primary efficacy endpoint is the complete response rate at week 12, while the secondary efficacy endpoints include the complete response rate at week 24; the partial response rate, overall response rate, and change in platelet count from baseline at both weeks 12 and 24; as well as time to response, drug-free remission duration, and response duration.
Study endpoints include primary endpoints such as dose - limiting toxicity (DLT), the type, severity, and frequency of adverse events (AE), and efficacy endpoints; secondary endpoints encompass the in - vivo expansion and persistence of universal STAR - T cells, main pharmacokinetic (PK) parameters (including peak expansion (Cₘₐₓ), time to peak (Tₘₐₓ), area under the blood concentration - time curve (AUC), and studies on cell subtypes and dominant clones), main pharmacodynamic (PD) parameters (such as changes in cytokines and the level and characteristics of immune cell reconstitution like CD19 - positive B cells), and immunogenicity - related studies (including the production of anti - drug antibodies (ADA) against universal STAR - T cells and replication - competent associated virus (RCA) in peripheral blood).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Universal STAR-T Cell | Experimental | Drug: Universal STAR-T CellSubjects will receive infusion of Universal STAR-T Cells at the starting dose of 3E6 STAR+T cells/kg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ranges from 18 to 65 years old (including threshold), regardless of gender.
- Confirmed diagnosis of a connective tissue disease (CTD) according to the latest international classification criteria, including but not limited to Systemic Lupus Erythematosus (SLE), Primary Sjögren's Syndrome (pSS), Antiphospholipid Syndrome (APS), and Undifferentiated Connective Tissue Disease (UCTD).
- Confirmed diagnosis of CTD-associated immune thrombocytopenia meeting one of the following:
- Platelet count < 30 × 10⁹/L; Platelet count < 50 × 10⁹/L accompanied by bleeding tendency.
- Bone marrow morphology consistent with the characteristics of immune thrombocytopenia (ITP).
Key exclusion criteria (14 listed)
- Subjects who meet any of the following exclusion criteria will not be admitted to the study:
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 |
|---|---|---|
| Universal STAR-T CellSubjects will receive infusion of Universal STAR-T Cells at the starting dose of 3E6 STAR+T cells/kg. | Drug | Universal STAR-T Cell |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs).
Time frame: Within 28 days after infusion
To assess the safety and tolerability of [Drug Name] and determine the Maximum Tolerated Dose (MTD) or Recommended Phase 2 Dose (RP2D). DLTs are defined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
9 secondary outcomes
Preliminary assessment of efficacy.
Time frame: The efficacy endpoint evaluation for 104 weeks.
Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time frame: AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks.
Maximum Plasma Concentration of YTS109 (Cmax) .
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Time to Reach Maximum Plasma Concentration (Tmax) of YTS109
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Area Under the Plasma Concentration-Time Curve (AUC) of YTS109
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
PD Biomarker Level Change (Cytokines Concentration).
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
PD Biomarker Level Change (B cells Quantification and Phenotypic).
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Immunogenicity: Anti-Drug Antibodies (ADA) against universal STAR-T cells
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Replication-Competent Adeno-Associated Virus (RCA) Detection
Time frame: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
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 20 May 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.
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 Universal STAR-T Cell in people with Immune Thrombocytopenia, run by Jian Zhu 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 16 inclusion and 14 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 20 May 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?
Contact Jian Zhu (8610-66937166, jian_jzhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs). (time frame: Within 28 days after infusion). 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 20 May 2026.