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Universal STAR-T Cell Injection in R/R Autoimmune Diseases.

2026년 5월 14일 업데이트: Jian Zhu

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.

연구 개요

상태

아직 모집하지 않음

상세 설명

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).

연구 유형

중재적

등록 (추정된)

6

단계

  • 1단계

연락처 및 위치

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연구 연락처

연구 장소

    • Beijing Municipality
      • Haidian, Beijing Municipality, 중국
        • No. 28, Fuxing Road, Haidian District, Beijing, China.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.
  2. 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).
  3. 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.

  4. Bone marrow morphology consistent with the characteristics of immune thrombocytopenia (ITP).
  5. 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:

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:

  1. Bone marrow: Neutrophils ≥1×10^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use).

    Hemoglobin ≥60 g/L.

  2. Liver: ALT/AST ≤3×ULN (disease-related elevations permitted). TBIL

    ≤1.5×ULN (disease-related elevations permitted).

  3. Renal: CrCl≥30mL/min (Cockcroft-Gault formula, excluding acute declines).
  4. Coagulation: INR/PT ≤1.5×ULN.
  5. 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.

Exclusion Criteria:

  • Subjects who meet any of the following exclusion criteria will not be admitted to the study:

    1. Individuals with a severe history of drug allergies or those with an allergic constitution;
    2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;
    3. 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);
    4. Subjects whose cardiac function cannot tolerate the study interventions;
    5. Subjects with congenital immunoglobulin deficiencies;
    6. Subjects with a history of malignant tumors within the past five years;
    7. Subjects with end-stage renal failure;
    8. 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;
    9. Subjects with psychiatric disorders or severe cognitive dysfunction;
    10. Subjects who have participated in other clinical trials within the past three months prior to enrollment;
    11. 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;
    12. Pregnant women or women planning to become pregnant;
    13. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Universal STAR-T Cell
Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 3E6 STAR+T cells/kg.
Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 3E6 STAR+T cells/kg.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Dose-Limiting Toxicities (DLTs).
기간: 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
Within 28 days after infusion

2차 결과 측정

결과 측정
측정값 설명
기간
Preliminary assessment of efficacy.
기간: The efficacy endpoint evaluation for 104 weeks.
1. Evaluation of preliminary efficacy based on relevant disease activity indices or response criteria.
The efficacy endpoint evaluation for 104 weeks.
Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs).
기간: AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks.
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.
AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks.
Maximum Plasma Concentration of YTS109 (Cmax) .
기간: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
To evaluate the maximum observed plasma concentration of YTS109.
Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Time to Reach Maximum Plasma Concentration (Tmax) of YTS109
기간: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
To evaluate the time to reach the maximum observed plasma concentration of YTS109
Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Area Under the Plasma Concentration-Time Curve (AUC) of YTS109
기간: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
To evaluate the total systemic exposure to YTS109 over time.
Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
PD Biomarker Level Change (Cytokines Concentration).
기간: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Evaluate the Pharmacodynamic (PD) effects of YTS109 cells.
Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
PD Biomarker Level Change (B cells Quantification and Phenotypic).
기간: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Evaluate the Pharmacodynamic (PD) effects of YTS109 cells.
Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Immunogenicity: Anti-Drug Antibodies (ADA) against universal STAR-T cells
기간: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
To evaluate the development of anti-drug antibodies (ADA) against allogeneic universal STAR-T cells in peripheral blood.
Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
Replication-Competent Adeno-Associated Virus (RCA) Detection
기간: Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.
To evaluate the presence of replication-competent adeno-associated virus (RCA) in peripheral blood.
Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 11일

기본 완료 (추정된)

2027년 5월 11일

연구 완료 (추정된)

2028년 5월 11일

연구 등록 날짜

최초 제출

2026년 5월 8일

QC 기준을 충족하는 최초 제출

2026년 5월 14일

처음 게시됨 (실제)

2026년 5월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 14일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Universal STAR-T Cell에 대한 임상 시험

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