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

NCT07599280 | Not Yet Recruiting Phase 1

• 1 other identifier: YTS109-006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Immune Thrombocytopenia

Keywords

CTD; Relapsed Refractory; Autoimmune

Outcome Measures

Primary Outcomes (1)

• 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

  Within 28 days after infusion

Secondary Outcomes (9)

• Preliminary assessment of efficacy.

  The efficacy endpoint evaluation for 104 weeks.

• Type, severity, and frequency of Adverse Events (AEs) and Serious Adverse Events (SAEs).

  AEs observation will be follow-up for 24 weeks. The observation period is extended to 104 weeks.

• Maximum Plasma Concentration of YTS109 (Cmax) .

  Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.

• Time to Reach Maximum Plasma Concentration (Tmax) 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

  Up to 24 weeks (Core Analysis Period); Extended observation up to 104 weeks.

Study Arms (1)

Universal STAR-T Cell

EXPERIMENTAL

Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 3E6 STAR+T cells/kg.

Drug: Universal STAR-T Cell

Interventions

Universal STAR-T Cell DRUG

Subjects will receive infusion of Universal STAR-T Cells at the starting dose of 3E6 STAR+T cells/kg.

Universal STAR-T Cell

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• At least one course of glucocorticoid pulse therapy; Or high-dose glucocorticoids combined with one or more immunosuppressants (including biologics).
• \. 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Jian Zhu: lead
• China Immunotech (Beijing) Biotechnology Co., Ltd.: collaborator

Study Sites (1)

No. 28, Fuxing Road, Haidian District, Beijing, China.

Haidian, Beijing Municipality, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Central Study Contacts

Jian Zhu

CONTACT

8610-66937166; jian_jzhu@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Department of Rheumatology and Immunology

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 20, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): May 11, 2027
• Study Completion (Estimated): May 11, 2028
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

CN (1)