Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND001

NCT05657184 | Completed Phase 1

• 1 other identifier: XHYX-IND-IPF-P1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

Idiopathic pulmonary fibrosis (IPF) is a condition where the lungs are damaged and scarred with unknown reason, making breathing becomes increasingly difficult.. REGEND001, made from airway basal cells with ability to regenerate lung tissue, is promising to IPF treatment. In this study, a single-armed clinical trial is ongoing to assess the safety and tolerability of REGEND001 in treatment of IPF. Different doses of REGEND001 is evaluated to establish a dose-response relationship and to suggest appropriate dose for subsequent clinical trials.

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of the cell therapy-related adverse events (AEs)

  Dose escalation is based on incidence of cell therapy-related AEs. Severity of cell therapy-related adverse events (AEs) is evaluated according to Common Terminology Criteria for Adverse Events (CTCAE).

  Within 24 weeks after treatment

Secondary Outcomes (16)

• Incidence of complication related to bronchoscopy

  Within 24 weeks after treatment

• Change in lung diffusing capacity for single-breath carbon monoxide (DLCO-sb) from baseline

  4, 12 and 24 weeks after treatment

• Change in forced vital capacity (FVC) from baseline

  4, 12 and 24 weeks after treatment

• Change in the ratio of diffusing capacity for carbon monoxide/ the alveolar volume (DLCO/VA) from baseline

  4, 12 and 24 weeks after treatment

• Change in 6-minute-walk test (6MWT) from baseline

  4, 12 and 24 weeks after treatment

Study Arms (1)

REGEND001

EXPERIMENTAL

Transplantation of autologous airway basal cells

Drug: REGEND001

Interventions

REGEND001 DRUG

Transplantation of REGEND001 for dose escalation.

REGEND001

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, aged between 50 to 75.
• Diagnosis of IPF according to 2018 Idiopathic Pulmonary Fibrosis Diagnostic Guidelines.
• Participants with 30%\~79% of the predicted value in diffusing capacity for carbon monoxide (DLCO) and more than 50% of the predicted value in forced vital capacity (FVC) in pulmonary function tests within 3 months before screening.
• Participants with typical HRCT images of IPF in the past 12 months.
• Participants tolerant to bronchofiberscopy.
• Participants fully informed with the purpose, method and possible discomfort of the trial, agreeing to participate in the trial and signing the informed consent voluntarily.
• Participants with good adherence, willing to take medication and regular follow-up examinations as required by the protocol.
• Participants able to understand and cooperate with the completion of pulmonary function tests.

You may not qualify if:

• Participants who cannot tolerate cell therapy.
• Pregnant or lactating women.
• Participants with syphilis or any of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) positive antibody; of which stable HBV carriers after drug treatment and cured hepatitis C patients can be enrolled.
• Participants with malignant tumors or a history of malignant tumors.
• Participants with a history of long-term use of drugs known to cause pulmonary fibrosis, such as amiodarone before screening.
• Participants with lung infections or other infections, including bacterial and viral infections, with requirement of intravenous medications before cell transplantation.
• Participants with a history of invasive or noninvasive mechanical ventilation within 4 weeks.
• Participants with any of the following lung diseases: asthma, active tuberculosis, pulmonary embolism, pneumothorax, pulmonary hypertension, pneumoconiosis, etc.; lung cancer, bronchiolitis obliterans or other active lung disease; pneumonia currently or in the past 4 weeks; pneumonectomy previously.
• Requirement of oxygen therapy for more than 15 hours per day.
• Suffering from serious diseases of other system.
• leukopenia or agranulocytosis of any cause; blood creatinine \> 2.5 times the upper limit of normal; alanine transaminase (ALT) and aspartate transaminase (AST) \> 2.5 times the upper limit of normal in the laboratory tests.
• Participants with a history of mental illness, suicide risk, epilepsy or other central nervous system disorders.
• Severe arrhythmias (such as ventricular tachycardia, frequent supraventricular tachycardia, atrial fibrillation, atrial flutter, etc.) or atrioventricular block of degree II or above, shown by 12-lead Electrocardiogram (ECG).
• Participants with a history of abusing alcohol or illicit drug.
• Participants allergic to cattle products.

Sponsors & Collaborators

• Regend Therapeutics: lead
• Peking Union Medical College Hospital: collaborator
• Ruijin Hospital: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Regend Therapeutics XLotus (Jiangxi) Co, Ltd.: collaborator

Study Sites (3)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 20, 2022
• Study Start: July 19, 2021
• Primary Completion: June 9, 2023
• Study Completion: June 9, 2023
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)