Plain-English translation of NCT06671236 on ClinicalTrials.gov ↗ · Source last updated · Translation generated · How we translate trials
Phase 1 — Testing in a small group (usually 20–80 people) to find a safe dose and watch for side effects.
This early-stage trial is testing a new treatment called NP001 cell injection for people with ALS (amyotrophic lateral sclerosis). The treatment uses your own immune cells, called regulatory T cells, which are collected from your blood, grown in a laboratory, and then carefully injected into your spinal fluid. The goal is to see if this approach is safe and whether it might help slow down the disease.
ALS is a progressive disease that damages nerve cells, leading to muscle weakness and paralysis. Current treatments like riluzole and edaravone can help slow progression, but new options are needed. This medication works on a different part of the immune system, which researchers believe may reduce harmful inflammation in the nervous system.
You likely qualify if…
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You would first have a procedure called apheresis, where blood is drawn from your arm and your immune cells are separated out and collected—similar to donating plasma. Those cells are then sent to a laboratory where they are grown and processed over several weeks. You would then return for three injections into your spinal fluid, given 4 weeks apart. After that, you would be followed for about 12 months total with regular visits to check your safety and how you're doing, including blood tests and neurological exams.
AI-generated summary from trial data · Jun 1, 2026 · Not medical advice
China
Phase
Safety & dosing
Sponsor
Novabio Therapeutics
Collaborators
The First Affiliated Hospital of Zhengzhou University
Enrollment target
~12 participants
Started
November 2024
Primary completion
December 2026
Age range
18 Years – 70 Years
Last updated on clinicaltrials.gov in September 2025.
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Central contact
Mingqi Lu, MD., PhD
Novabio Therapeutics
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