Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 1interventionalRules rewrite

Phase 1: testing YTS109 cell for Systemic Lupus Erythematosus (SLE)

This study evaluates the safety and how well it works of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc. Aproximately 6-12 patients aged 18-65 will receive a single infusion of YTS109 cells (1.5×10⁶ cells/kg).

Official registry: https://clinicaltrials.gov/study/NCT06978647 · China Immunotech (Beijing) Biotechnology Co., Ltd. · enrollment listed as 12

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

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 cell. The registry lists allocation as na. This study evaluates the safety and how well it works of YTS109 cells in adults with relapsed/refractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), etc.

They plan to enroll about 12 people at Beijing. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

An Exploratory Clinical Study of YTS109 Cell in Subjects With Relapsed/Refractory Autoimmune Diseases

Interventions: YTS109 cell

Primary outcome (registry wording): Incidence of Treatment-Emergent Adverse Events

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Subjects must meet both the following common who can join and disease-specific who can join simultaneously to be eligible for participation in this study:
  • Common who can join:
  • Age ranges from 18 to 65 years old (including threshold), regardless of gender
  • Detection of positive CD19 expression on peripheral blood B cells by flow cytometry
  • Essential Organ Function Criteria:
  • Bone marrow: Neutrophils ≥1×10\^9/L (within 2 weeks, excluding granulocyte colony-stimulating factor use)
  • Hemoglobin ≥60 g/L

Public study contact (from the registry)

Jian Zhu

8610-66937166

jian_jzhu@126.com

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

Sites listed on ClinicalTrials.gov

1 listed

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FAQ about this NCT record

Is NCT06978647 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 NCT06978647?

Phase 1. 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 NCT06978647?

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