JY231(Internal Clinical Drug Code) Injection for the Treatment of Refractory Autoimmune Diseases

NCT06243159 | Not Yet Recruiting Early Phase 1

• 1 other identifier: JY-CT-23-007
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of refractory autoimmune diseases

Conditions

Autoimmune Diseases

Keywords

JY231 injection

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  Metric/method of measurement: (2007)《Revised response criteria for malignant lymphoma》

  Day 0、Month 1、Month 2、Month 3、Month 6、Month 12

Study Arms (1)

JY231 injection for the treatment of refractory autoimmune diseases (ADs) Early exploratory clinica

EXPERIMENTAL

Infusion of JY231 Injection by dose of 1-10×10\^6 transducing units(TU)/kg、 1-5×10\^7 TU/kg、5-10 ×10\^7 TU/kg Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)

Genetic: JY231

Interventions

JY231 GENETIC

Infusion of JY231 Injection by dose of 1-10×10\^6 TU/kg、 1-5×10\^7 TU/kg、5-10 ×10\^7 TU/kg Administration method: intravenous infusion、Splenic artery infusion、Lymph node infusion; Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion (PI evaluation is required)

Also known as: Fludarabine, Cyclophosphamide

JY231 injection for the treatment of refractory autoimmune diseases (ADs) Early exploratory clinica

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 18-65 years old, regardless of gender, signed with informed consent (ICF).
• Diagnosed as one of the following diseases: Systemic lupus erythematosus (SLE)；Sjogren's syndrome (SS) ; Systemic Scleroderma (SSc); Dermatomyositis (DM); Anti neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV).
• Patients who have been treated with ≥ 2 immunosuppressive agents for 3 months, or require ≥ 15mg glucocorticoids to maintain stable condition, or are intolerant to standard treatment, or have relative contraindications, and whose disease activity meets the following criteria:
• For SLE patients, SLEDAI ≥ 8 points;
• For SS patients, Sjogren's syndrome disease activity index(ESSDAI )≥ 14 points;
• For SSc patients, the modified Rodnan skin score (mRSS) score ranges from 10 to 35 (including cutoff values) and is associated with interstitial pneumonia (ILD);
• For DM patients, diagnosed for at least 1 year;
• For ANCA-AAV patients, Birmingham Vasculitis Activity Score(BVAS) score ≥ 15 and ANCA antibodies.
• Eastern Cooperative Oncology Group(ECOG) 0-1 points;
• The evaluation of important organ functions meets the following conditions:
• Blood count: hemoglobin ≥ 60g/L, platelet count ≥ 30 × 109/L;
• Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 55%, no significant abnormalities observed on electrocardiogram;
• Renal function: estimated glomerular filtration rate(eGFR) ≥ 30 mL/min/1.73m2;
• Liver function: Aspartate Aminotransferase(AST) and Alanine Transaminase(ALT) ≤ 3.0 upper limit of normal(ULN), total bilirubin ≤ 2.0 ULN;
• Pulmonary function: diffusion capacity of the lung for carbon monoxide(DLCO) ≥ 40% expected value; forced vital capacity(FVC) ≥ 50% of expected value;

You may not qualify if:

• Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;
• Suffering from severe diseases of the heart, liver, lungs, blood system, and endocrine system, the researcher has determined that the risk of participating in the trial is higher than the benefit;
• Active or uncontrollable infections that require systemic treatment within the first week of screening;
• Previously received hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or screened for acute graft-versus-host disease (GVHD) with grade 2 or above in the first two weeks;
• Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the hepatitis B virus(HBV) DNA titer in peripheral blood is greater than the normal reference value; Or hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA titer detection greater than the normal reference range; Or positive for human immunodeficiency virus (HIV) antibodies; Or those who test positive for syphilis; Or positive for cytomegalovirus (CMV) DNA detection;
• Received live vaccine within 4 weeks prior to screening;
• Pregnancy test positive individuals;
• Patients with malignant tumors and other malignant diseases before screening, in addition to fully treated cervical cancer in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;
• Screening patients who have participated in other clinical trials within the first three months;
• Other researchers believe that it is not suitable to participate in this study.

Sponsors & Collaborators

• Shanxi Bethune Hospital: lead

Study Sites (1)

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

Location

MeSH Terms

Conditions

Autoimmune Diseases

Interventions

fludarabine; Cyclophosphamide

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• liyun zhang, Doctoral

  Shanxi Bethune Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liyun zhang, Doctoral

CONTACT

13834547708; 1315710223@qq.com

qianyu guo, Doctoral

CONTACT

18835137516; 18835137516@139.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: February 6, 2024
• Study Start: February 8, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 6, 2024

Record last verified: 2024-01

Locations

CN (1)