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Safety Study of XT-150 for ALS

This study is testing the safety of a new treatment called XT-150 in people with Amyotrophic Lateral Sclerosis (ALS). XT-150 is a small piece of genetic material designed to produce a variant of Interleukin 10 (IL-10), which is a protein that helps reduce inflammation. We want to find out what side effects XT-150 might cause and if it affects your physical health, vital signs, or lab results. This is a small study, planning to enroll 8 adults between 18 and 80 years old who have been diagnosed with ALS. The main goal is to understand the safety of XT-150 over 180 days (6 months) after a single injection.

Study design
This is a Phase 1, open-label study, meaning both you and the study doctors will know which treatment you are receiving. It will involve 8 participants in total.
What's involved
You will receive a single injection of XT-150 at the start of the study. You will then have follow-up visits over 180 days (6 months) after the injection.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 180 days (6 months) after receiving the injection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06704347

Safety Study of XT-150 in Participants With ALS

Not Yet Recruiting
PHASE1Ages 18–80InterventionalTreatment
Xalud Therapeutics, Inc.
~8 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:XT-150

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants reporting adverse events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)
Measured over Up to Day 180
+3 more outcomes measured

Conditions

Amyotrophic Lateral Sclerosis (ALS)

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Amyotrophic Lateral Sclerosis

NCT06704347

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Henry Ford Health

    Detroit, Michiganstudy coordinator listed

  • Johns Hopkins University

    Baltimore, Marylandstudy coordinator listed

  • Massachusetts General Hospital

    Boston, Massachusettsstudy coordinator listed

  • Barrow Neurological Institute (St. Joseph's)

    Phoenix, Arizonano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Director of Medical Information
[email protected]
212-301-6673
Email the study team

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Eligibility criteria

Inclusion

Adults between 18 and 80 years of age
Male or female, if of childbearing potential or sexually active, strict contraception required
Have ALS diagnosed by a doctor (specifically, sporadic or familial ALS diagnosed as clinically probable, lab-supported probable or definite ALS defined by the El Escorial criteria)
Have had symptoms of ALS (muscle weakness) within 36 months of starting this study
Have the ability to slowly exhale a volume of air at least 60% of what is expected for the participant's sex, height and age
Have not received treatment for ALS or are currently on a stable dose of an approved treatment for ALS. Patients currently receiving Tofersen are not eligible.
Able to receive the study injection intrathecally, determined by the study doctor
Able to undergo the study procedures and adhere to the study visit schedule at the time of study entry, with an estimated life expectancy of 6 months or greater

Exclusion

Have an implanted shunt to drain cerebrospinal fluid (CSF) or an implanted CNS catheter
Have an implanted of diaphragm pacing system
Tracheostomy
History or current diagnosis of cardiac conditions or ECG abnormalities indicating significant risk of safety for participants in the study
History or current diagnosis of respiratory conditions such as COPD
History or current diagnosis of cancer, chemical meningitis, HIV, Hep B, Hep C, uncontrolled diabetes
Presence of an autoimmune condition (for example, rheumatoid arthritis or lupus) requiring treatment or immunodeficiency
Clinical or laboratory evidence of hepatic or renal disease/injury.
Taking any prohibited medications
Women who are pregnant or nursing
Use of any investigational drugs or devices within 30 days or 5 half-lives of the study agent (whichever is longer). Exception: Observational, non-interventional clinical studies are allowed in the opinion of the study doctor.
Any other condition that the study doctor feels could compromise the participant's safety, ability to communicate with the study staff, or the quality of the data

What this trial measures

  • Number of participants reporting adverse events (AEs), Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)Up to Day 180
  • Number of participants with clinically significant physical examination findingsUp to Day 180
  • Number of participants with clinically significant vital sign abnormalitiesUp to Day 180

    Vital signs include temperature, heart rate, respiratory rate and blood pressure

  • Number of participants with clinically significant laboratory abnormalitiesUp to Day 180

    Clinical laboratory assessments include hematology, chemistry, coagulation, lipids, C-reactive protein, erythrocyte sedimentation rate and CSF total protein, cell count and glucose