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CAR T-cell Therapy

Regulatory T Cells for ALS

Phase 1
Recruiting
Research Sponsored by Novabio Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AD patients aged 65 or above with clinical diagnosis of AD, stable doses of medication, normal blood tests, able to provide written informed consent
Must have autologous T cell source sufficient for NP001 T cells
Must not have
Current use of specified medications
< 3 drugs do not adequately control hypertension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

"This trial is testing the safety and effectiveness of injecting a patient's own regulatory T cells into individuals with neurodegenerative diseases like ALS, MSA, and AD."

Who is the study for?
This trial is for individuals with neurodegenerative diseases like ALS, Alzheimer's, and Multiple System Atrophy. Participants must have a confirmed diagnosis and be in stable condition to receive T cell injections.
What is being tested?
The study tests the safety and potential benefits of injecting patients' own regulatory T cells (NP001 cell injection) to treat various neurodegenerative conditions.
What are the potential side effects?
Since this is an early-phase trial, specific side effects are being studied; however, they may include immune reactions or discomfort at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 or older with Alzheimer's, on stable medication, and can consent.
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I have enough of my own T cells for the NP001 T cell treatment.
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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently taking certain medications.
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My high blood pressure is not controlled by 3 or fewer medications.
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I have a serious heart condition.
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I currently have an infection that is not under control.
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I have a history of serious tumor, liver, or kidney disease.
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I have a feeding tube.
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I have previously received gene or cell therapy for ALS, MSA, or AD.
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I am not willing to use birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Identification of Maximum Tolerated Dose (MTD)
Incidence of Treatment Related adverse events (AEs)
Secondary study objectives
Amyotrophic lateral sclerosis functional rating scale- revised (ALSFRS-R)
Clinical Dementia Rating (CDR)
Montreal Cognitive Assessment (MoCA)
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Autologous Human Polyclonal Regulatory T Cells Injection (NP001 Cell Injection)Experimental Treatment1 Intervention
Regulatory T cell therapy, intrathecal injection

Find a Location

Who is running the clinical trial?

The First Affiliated Hospital of Zhengzhou UniversityOTHER
348 Previous Clinical Trials
649,176 Total Patients Enrolled
Novabio TherapeuticsLead Sponsor
~8 spots leftby Dec 2026
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