NCT06671236

Clinical Study of Regulatory T Cells (Tregs) in the Treatment of Neurodegenerative Diseases

An Open, Single-Arm, Multi-Center Clinical Study to Evaluate the Safety and Tolerability of Regulatory T Cells (Tregs) In the Treatment of Neurodegenerative Diseases

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Novabio Therapeutics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

An open, multi- center phase Ⅰ clinical study evaluating the safety and efficacy of autologous human polyclonal regulatory T cell injection (NP001 cell injection) in patients with Neurodegenerative diseases (ALS).

Detailed description

This is an open-label, non-randomized, multi-center clinical trial of single-agent NP001 cell injection in patients with with Neurodegenerative diseases (ALS). After subject consents to the study, an apheresis procedure will be performed to collect cells to manufacture the investigational product, NP001 cell injection. NP001 cell injection are manufactured ex vivo to yield enriched Tregs. This study is evaluating NP001 cell injection at the dose of 1x E6 cells, 1x E7 cells, and 1x E8 cells/times, with up to 3 times separated by 4 weeks among dosing (intrathecally on Days 1, 29, and 57). Study subjects are then followed for several months to capture safety and efficacy parameters. The total duration of NP001 cell injection and follow-up interval on this protocol is approximately 12-months.

Conditions

• Amyotrophic Lateral Sclerosis (ALS)

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Human Polyclonal Regulatory T Cells Injection (NP001 Cell Injection)	Regulatory T cell therapy, intrathecal injection

Timeline

• Start date: 2024-11-21
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-11-04
• Last updated: 2025-09-25

Locations

1 site across 1 country: China