Treatment of Chronic Obstructive Pulmonary Disease (COPD) by REGEND007 Cell Therapy
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age40-80
SponsorRegend Therapeutics
About this trial
Chronic obstructive pulmonary disease (COPD) is the third leading cause of death worldwide with the characterization of obstructed airflow. In a large number of patients, diffusion function is impaired along with the progression of disease. REGEND007 cell therapy, comprised of airway basal cells with ability to regenerate lung tissue, is promising to COPD treatment. A prospective, single-arm, dose-escalation exploratory clinical study to evaluate the safety, tolerability and preliminary efficacy of different doses of REGEND007 cell therapy administered by intravenous infusion in the treatment of COPD, and to recommend appropriate treatment doses for subsequent clinical studies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gender is not restricted; when signing the informed consent form, the age should be between 40 and 80 years old (inclusive of the boundary values);
Diagnosed with COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) in 2025;
During the screening process, the six-minute walk test should be ≥ 150 meters and < 600 meters;
Voluntarily sign the informed consent form, be able to cooperate with the completion of the research-related procedures and examinations, and be able to describe or record the changes in the condition in a relatively complete manner.
Disqualifiers
Female subjects who are pregnant, breastfeeding, or planning to become pregnant within one year after using this product; or male subjects whose spouses are planning to become pregnant.
Subjects evaluated by the investigator at the time of screening have a survival period of less than one year.
Subjects with a current or past history of malignant tumors (excluding non-melanoma skin cancer, cervical cancer in situ, bladder cancer, thyroid cancer, and breast cancer, etc., which have a disease-free survival of more than five years and are judged by the investigator to have a relatively weak invasiveness) at the time of screening.
Subjects diagnosed with pneumonia (including bacterial, fungal, or viral pneumonia) within 4 weeks before screening.
Trial design
Design model
Sequential
Treatments tested in this trial
REGEND007
Biological/VaccineThis study's intravenous infusion dose escalation protocol is based on a 3+3 dose escalation design, with a total of 4 dose groups. Each group included 3 subjects, and the dose is gradually increased until the maximum tolerated dose (MTD) or the maximum administered dose (MAD) is reached.
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: REGEND007 Cell TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence and severity of drug-related adverse events (AEs)
All adverse medical events that occur from the time the subject signs the informed consent form. These can manifest as symptoms, signs, diseases, or abnormal laboratory test results, but they do not necessarily have a causal relationship with the investigational drug
Time frame
Within 12 weeks after administrationSecondary outcomes
1
The time of the first occurrence of acute exacerbation of COPD (AECOPD) after administration
The time of the first occurrence of acute exacerbation of COPD (AECOPD) after administration is an important indicator for assessing the severity and prognosis of the disease.
Time frame
Within 12 weeks after the last administration2
The changes in the annual incidence of AECOPD after administration compared to before administration
The changes in the annual incidence of AECOPD after administration compared to before administration is an important indicator for assessing the severity and prognosis of the disease.
Time frame
12 weeks after administration3
The change in the forced vital capacity (FVC) actual-to-predicted ratio compared to baseline
FVC is the full amount of air that can beexhaled with effort in a complete breath
Time frame
24 hours after administration, 4 and 12 weeks after the last administration4
The changes in forced expiratory volume in one second (FEV1) actual-to-predicted ratio compared to baseline
FEV1 is the volume of breath exhaled with effort in one second.
Time frame
24 hours after administration, 4 and 12 weeks after the last administration.Sponsors and contacts
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Source ClinicalTrials.gov