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Allogeneic Mitochondria (PN-101) Transplantation for Refractory Polymyositis or Dermatomyositis

Dermatomyositis Clinical Trial

Official title:
A Prospective, Open, Dose-escalation, Multi-center, Phase 1/2a Trial to Evaluate the Safety, Tolerability and to Explore the Efficacy of PN-101 in Patients With Refractory Polymyositis or Dermatomyositis

Clinical Trial Summary

To determine the maximum tolerated dose (MTD) based on the safety and tolerability after single-dose administration of PN-101 in patients with refractory polymyositis or dermatomyositis. To explore the efficacy after single-dose administration of PN-101 in patients with refractory polymyositis or dermatomyositis.

Clinical Trial Description

This Phase 1/2a clinical trial involves patients diagnosed with refractory polymyositis or dermatomyositis. The initial safety assessment is conducted, including development of DLT in subjects up to Week 2 after the investigational product administration. [DLT assessment criteria and method] - Low dose or intermediate dose level 1. No DLT developing in the initially enrolled 3 subjects (0/3): Increase the dose to the next dose group 2. DLT developing 1 of 3 subjects (1/3): Enroll 3 additional subjects at the same dose group and then assess DLT, and ① DLT developing in 1 out of total 6 subjects (1/3+0/3; 1/6): Increase the dose to the next dose group ② DLT developing in ≥ 2 out of total 6 subjects (≥ 2/6): In case of the low dose level, the trial is discontinued without MTD determination. In case of the intermediate dose level, MTD is assessed at the low dose which is a one lower dose level - High dose level 1. No DLT developing in the initially enrolled 3 subjects (0/3): Declare as the MTD 2. DLT developing 1 of 3 subjects (1/3): Enroll 3 additional subjects at the same dose group and then assess DLT, and ① DLT developing in 1 out of total 6 subjects (1/3+0/3; 1/6): Declare as the MTD ② DLT developing in ≥ 2 out of total 6 subjects (≥ 2/6): Assess MTD at the intermediate dose which is the one lower dose level ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04976140
Study type Interventional
Source Paean Biotechnology Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 15, 2021
Completion date October 6, 2023
View Details
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