Safety, Tolerability and Efficacy of VUM02 Injection in Treatment of Idiopathic Pulmonary Fibrosis (IPF)

Sponsor
Wuhan Optics Valley Vcanbiopharma Co., Ltd.
Study ID
NCT06230822
Phase
PHASE1
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • VUM02 Injection — DRUG
    VUM02 Injection will be administered intravenously every 3 days for a total of 3 doses.

Study Details

This study is a single-arm, multiple-dose, dose-escalation, open-label multicenter clinical trial, aiming to evaluate the safety, tolerability, and preliminary efficacy of VUM02 Injection for treatment of idiopathic pulmonary fibrosis (IPF). VUM02 Injection (Human Umbilical Cord Tissue-derived Mesenchymal Stem Cells Injection, hUCT-MSC) is an allogeneic cell therapy product comprising culture-expanded Mesenchymal Stem Cells derived from the human umbilical cord tissue. The product is cryopreserved with the amount of 5 x 10\^7 cells per 10 mL per bag (5 x 10\^6 cells/mL). This study is a multiple-dose tolerability study following the "3+3" dose escalation principle and progressing from the low-dose group to the high-dose group sequentially. Three to six patients will be enrolled in each dose group and administered every 3 days for a total of 3 doses.

Key Dates

First listed
Jan 30, 2024
Start date
Feb 29, 2024
Status verified
Jan 2024
Primary completion
Jan 31, 2025
Completion
Dec 31, 2026

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VUM02 Injection (hUCT-MSCs)+Conventional treatment
    3 predefined dose groups: 5x10\^7 cells/person/time, 1x10\^8 cells/person/time and 2x10\^8 cells/person/time, administered intravenously on D0, D3 and D6 for a total of 3 doses.

Primary Outcome Measure

Incidence and severity of cell therapy-related adverse events (AEs) as assessed by CTCAE (V5.0) [ Time Frame: 28 days ]

Central Contacts

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