RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: YTS109 for Systemic Lupus Erythematosus

Q: Is NCT06379646 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

Q: What phase is NCT06379646?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Q: Can PlainTrials tell me if I qualify for NCT06379646?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

An exploratory clinical study of the safety and how well it works of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease

Official registry: https://clinicaltrials.gov/study/NCT06379646 · China Immunotech (Beijing) Biotechnology Co., Ltd. · enrollment listed as 6

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are YTS109. The registry lists allocation as na. An exploratory clinical study of the safety and how well it works of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease

They plan to enroll about 6 people at Shanghai. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

An Exploratory Clinical Study of the Safety and Efficacy of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease

Interventions: YTS109

Primary outcome (registry wording): Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
Age ranges from 18 to 65 years old (including threshold), regardless of gender
Positive expression of CD19 on peripheral blood B cells determined by flow cytometry
The functions of important organs meet the following requirements:
Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×109/L; Hemoglobin ≥60g/L;
Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;
Renal function: creatinine clearance (CrCl) ≥30 ml/minute;
Coagulation function: International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN;

Who the registry excludes

People with severe drug allergy or allergic constitution;
the presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;
Subjects with central nervous system disorders (excluding pre-existing epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis as a result of the disease);
Patients with cardiac dysfunction;
Subjects with congenital immunoglobulin deficiency;
History of malignant tumor in recent five years;
Subjects with end-stage renal failure;

Public study contact (from the registry)

Huji Xu

8602181886999

xuhuji@smmu.edu.cn

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (recruiting)

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FAQ about this NCT record

Is NCT06379646 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06379646?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06379646?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary