Lupus Nephritis (LN)Phase 1NCT06943937
A Clinical Study of YTS109 Cell in R/R Systemic Lupus Erythematosus
A Phase 1 study testing YTS109 cell injection in people with Lupus Nephritis (LN) and Immune Thrombocytopenia (ITP), run by China Immunotech (Beijing) Biotechnology Co., Ltd. at 1 site in China.
Trial summary
This study evaluates the safety and efficacy of YTS109 cells in adults with refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus-Immune Thrombocytopenia (SLE-ITP). Approximately 36 patients aged 18-65 will receive a single infusion of YTS109 cells (1×10⁶-2×10⁶ cells/kg). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis (LN), Immune Thrombocytopenia (ITP)
- What is being tested?
- YTS109 cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2025to 25 Apr 2026
- Phase
- Phase 1
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
- Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:
- Age ranges from 18 to 65 years old (including threshold), regardless of gender.
- Meet the EULAR/ACR 2019 SLE Classification Criteri:
- Cohort 1: Refractory Lupus Nephritis: Defined as failure to achieve remission after treatment with corticosteroids and ≥2 immunosuppressants (e.g., CTX, tacrolimus, MMF, cyclosporine) and/or biologics, with urine protein/creatinine ratio (UPCR ≥1.0 g/g) , and renal pathology requirement scriteria: ISN/RPS 2003 Class III/IV proliferative lupus nephritis (or combined with type V features) , with ≤50% glomerulosclerosis.
- Cohort 2: Refractory Immune Thrombocytopenia: Requires treatment failure with: Failed treatment with at least 1 course of MP shock (1g for 3 days) or high- dose glucocorticosteroids (1mg/kg/d equivalent dose of glucocorticosteroids) in combination with 1 or more immunosuppressive agents. At least 2 consecutive routine blood tests for platelets less than 50×10^9/L and >30×10^9/L were performed prior to enrolment. other non-SLE causes of thrombocytopenia, such as infections, myelosuppression and hypersplenism, were excluded.
- 3. Essential Organ Function Criteria:
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- 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. 4. 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.
- 5. Voluntary participation with signed informed consent and compliance.
- Exclusions Criteria:
- Subjects who meet any of the following exclusion criteria will not be admitted to the study:
- Severe drug allergies or hypersensitivity.
- Uncontrolled/untreated infections (fungal, bacterial, viral, etc.).
- CNS disorders (exceptions: epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, CNS vasculitis).
- Heart failure intolerance.
- Congenital immunoglobulin deficiency.
- Malignancy within 5 years (exceptions: localized cancers with negligible metastasis risk).
- End-stage renal failure.
- Subjects positive for: HBsAg / HBcAb with HBV DNA > detection limit; HCV Ab + HCV RNA; HIV Ab; Syphilis test.
- Deep vein thrombosis/pulmonary embolism within 6 months pre- screening.
- Severe mental illness/cognitive impairment.
- Participation in other clinical trials within 3 months pre-screening.
- Use of immunosuppressants (within 5 half-lives) or biologics (within 4 weeks) pre-screening.
- Pregnancy/breastfeeding or planned conception.
- Other researcher-determined ineligibility.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Clinical Study of YTS109 Cell in Subjects With Refractory Disease Systemic Lupus Erythematosus
This study evaluates the safety and efficacy of YTS109 cells in adults with refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus-Immune Thrombocytopenia (SLE-ITP). Approximately 36 patients aged 18-65 will receive a single infusion of YTS109 cells (1×10⁶-2×10⁶ cells/kg). The primary endpoint is observations of types, severity, and frequency of dose-limiting toxicities (DLTs) and adverse events (AEs). Secondary endpoints include the complete renal response (CRR) rate at week 12 in LN, and proportion of subjects achieving complete response (CR) or partial response (PR) at week 12 post-treatment in SLE-ITP. This single-arm, open-label trial will enroll patients across Beijing GoBroad Hospital in China.
Read the detailed description
Background: Systemic lupus erythematosus (SLE) is characterized by multi-system and multi-organ involvement, recurrent flares and remissions, and the presence of numerous autoantibodies. LN and SLE-ITP are the most common and severe clinical manifestations of SLE. Recently, the therapeutic advancements have been made in the management of SLE. However, the patients with refractory SLE, particularly those complicated by LN and SLE-ITP, continue to face significant unmet clinical needs. CAR-T cell therapy has emerged as one of the innovative therapeutic modalities for autoimmune diseases, characterized by its controllable safety profile and durable therapeutic efficacy, warranting further clinical exploration and investigation in the future. YTS109 cell is a universal allogeneic STAR-T cell therapy targeting CD19, designed to efficiently eliminate B cells in patients with SLE and mitigate autoimmune responses. Design: This is a single-center, single-arm, prospective exploratory clinical trial designed to evaluate the safety profile, preliminary therapeutic efficacy, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of YTS109 cell therapy in patients with refractory SLE. Approximately 36 patients aged 18-65 will receive a single infusion of YTS109 cells (1×10⁶-2×10⁶ cells/kg). The primary endpoint is observations of types, severity, and frequency of dose-limiting toxicities (DLTs) and adverse events (AEs). This study was approved by the IRB of Beijing GoBroad Hospital (Approval Number: RP2025-013-002), All participants provided written informed consent.
- Being tested
- YTS109 cell injection
- Medical subject headings
- Lupus Nephritis, Purpura, Thrombocytopenic, Idiopathic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YTS109 cell injectionDrug
Subjects will receive YTS109 Cell Injection(1E6 STAR+T cell/kg or 2E6 STAR+T cell/kg) once in this study.
| Study group | Role | What they receive |
|---|---|---|
| YTS109 cell | Experimental | Subjects will receive YTS109 cell (1E6 STAR+T cell/kg or 2E6 STAR+T cell/kg) once in this study. Receives: Drug: YTS109 cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
- Dose-limiting toxicity (DLT);
- Types, severity, and frequency of adverse events (AEs).
Measured: 28 days for DLT during the treatment assessment period, and observation AEs will be conducted up to 52 weeks post-treatment.
Secondary outcomes (6)
Efficacy Evaluation in LN
The proportion of subjects who achieved complete renal response (CRR) at 12 weeks
Measured: The complete renal response (CRR) rate at week 12 in LN, and observation will be conducted up to 52 weeks post-treatment.
Efficacy Evaluation in SLE-ITP
The proportion of subjects achieving complete response (CR) or partial response (PR) at 12 weeks
Measured: The proportion of subjects achieving complete response (CR) or partial response (PR) at week 12 post-treatment in SLE-ITP, and observation will be conducted up to 52 weeks post-treatment.
Peak Plasma Concentration (Cmax) of YTS109
To evaluate the metabolic characteristics of YTS109
Measured: These detections will be conducted up to 52 weeks post-treatment.
Time to Peak (Tmax) of YTS109
To evaluate the metabolic characteristics of YTS109
Measured: These detections will be conducted up to 52 weeks post-treatment.
Area under the plasma concentration versus time curve (AUC) of YTS109
To evaluate the metabolic characteristics of YTS109
Measured: These detections will be conducted up to 52 weeks post-treatment.
PD parameters
Changes in B cells quantification and phenotypic in peripheral blood
Measured: These detections will be conducted up to 52 weeks post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start16 Apr 2025
- Primary completion25 Apr 2026
- Study completion25 Apr 2026
Why it stopped: Sponsor decision to discontinue; the study is no longer being pursued due to sponsor strategic reprioritization and resource allocation. The decision was not based on safety concerns. Enrolled participants will complete safety follow-up per protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Nephritis (LN)Studies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943937
- Sponsor's protocol ID
- YTS109-005
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No