JY231(JY231) Injection for the Treatment of Refractory Autoimmune Diseases (ADs)

ConditionAutoimmune Diseases

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorHe Huang

About this trial

This study is an investigator-initiated single center, single arm clinical study with a target population of patients with Refractory Autoimmune Diseases (ADs). It is an early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of Refractory Autoimmune Diseases (ADs).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 18~75 years old, male or female, signed informed consent (ICF);

Systemic Lupus Erythematosus (SLE), European League Against Rheumatism/ (EULAR)/American College of Rheumatology(ACR) 2019 criteria), and Antinuclear Antibodies(ANA) > 1:80 or ds-DNA positive;

Dry syndrome (SS), 2016 ACR/EULAR criteria and at least Sjögren's Syndrome Antigen A(SSA) positive;

Systemic sclerosis (SSc), 2013 ACR/EULAR criteria and ANA > 1:80 or anti-Scleroderma(SCL)-70 positive;

Disqualifiers

Have received prior CAR-T cell therapy;

Suffering from severe cardiac, hepatic, pulmonary, hematologic, or endocrine system disorders that, in the judgment of the investigator, outweigh the risks of participation in the study;

Active or uncontrollable infection requiring systemic therapy within 1 week prior to screening;

Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) positive and peripheral blood Hepatitis B virus (HBV) DNA titer test is greater than the normal reference range; or Hepatitis C virus (HCV) antibody positive and peripheral blood Hepatitis C virus (HCV) RNA titer test is greater than the normal reference range; or Human Immunodeficiency Virus (HIV) antibody positive; or positive syphilis test; or positive cytomegalovirus (CMV) DNA test;

Trial design

Design model

Single group

Treatments tested in this trial

JY231 Injection
Drug
This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo chimeric antigen receptor T-Cell (CAR-T cell) therapy in patients with relapsed refractory B-cell leukemia. Upon enrollment, subjects will receive an intravenous infusion of the JY231 preparation. Following the infusion, subjects will be hospitalized for one month for observation, and subjects will be evaluated for safety and efficacy. Subjects will be followed for up to 15 years to determine if the disease is under control.

Treatment groups

45 Participants

are divided into 1 treatment group

Group A: A single-center, open, single arm studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of adverse events(AE) after infusion

The frequency, severity, and laboratory findings of all adverse events/serious adverse events are included.

Time frame

Day 28、Month 2、Month 3、Month 6、Month 12、Month 18、Month 24

Maximal Tolerated Dose(MTD)

MTD will be determined based on Dose-Limiting Toxicity(DLTs) observed during the first 28 days of study treatment.

Time frame

Up to 28 days after infusion

Locations

This trial has no locations.

Sponsors and contacts

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

He Huang

Lead sponsor

Zhejiang University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: