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An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent/Refractory Autoimmune Disease

ConditionsSystemic Lupus ErythematosusSystemic SclerosisInflammatory MyopathyAnti-Neutrophil Cytoplasmic Antibody-Associated VasculitisAntiphospholipid SyndromeSjogren's Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorChina Immunotech (Beijing) Biotechnology Co., Ltd.

About this trial

An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent/refractory autoimmune disease

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • YTS109

    Other intervention

    Subjects will receive YTS109 Cell Injection(3E6STAR+T cell/kg) once in this study.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: YTS109Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Safety assessments are conducted using the NCI-CTCAE version 5.0 standards.

Time frame
3 months for safety measurements during the treatment assessment period
2

Efficacy outcomes for SLE

SLE Response index 4(SR-4) response: Min/Max Value: Not specife: a decrease in score indicates improvement: hicher scores indicate worse outcome

Time frame
3 months for efficacy measurements during the treatment assessment period
3

Efficacy outcomes for Sjogren's Syndrome

Sjogren's tool for assessing response (STAR): Min/Max Value: Not specified: a decrease n score indicates improvement: higher scores indicate worse outcome

Time frame
3 months for efficacy measurements during the treatment assessment period
4

Efficacy outcomes for Systemic Sclerosis

ACR-CRISS score (CRISS score ≥0.6 improvement, \< 0.6 no improvement) and modified CRISS score (rCRISS score) (percentage of patients with at least 3 of the 5 core items of ACR-CRISS improved by a certain percentage (e.g. 25%, except FVC (5%))

Time frame
3 months for efficacy measurements during the treatment assessment period

Secondary outcomes

1

Peak Plasma Concentration (Cmax) of YTS109

To evaluate the metabolic characteristics of YTS109

Time frame
3 and 6 months
2

Time to Peak (Tmax) of YTS109

To evaluate the metabolic characteristics of YTS109

Time frame
3 and 6 months
3

Area under the plasma concentration versus time curve (AUC) of YTS109

To evaluate the metabolic characteristics of YTS109

Time frame
3 and 6 months
4

PD parameters

Changes in cytokines in peripheral blood

Time frame
3 and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

China Immunotech (Beijing) Biotechnology Co., Ltd.

Lead sponsor

Shanghai Changzheng Hospital

Collaborator

Source ClinicalTrials.gov
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