Actively Recruiting
A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
Led by ITB-Med LLC · Updated on 2026-03-31
48
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the safety, pharmacokinetics, and pharmacodynamics of TCD601 (siplizumab) in adults newly diagnosed with amyotrophic lateral sclerosis (ALS). This study focuses on how the drug affects immune cells in the blood and cerebrospinal fluid and monitors disease progression and related changes over time. The trial is a phase 1 study conducted over 52 weeks. Participants will receive TCD601 alongside the current standard care for ALS. The treatment's distribution in the body and its effects on immune markers will be studied in detail. This trial does not use a placebo group, and all participants will receive the investigational product. During the study, participants will undergo safety evaluations, laboratory tests, vital sign monitoring, and measurements of biomarkers and immune cell profiles. The trial will also track the time from entry to events such as tracheostomy or death. These assessments will occur over the full 12 months to understand the treatment's safety and biological impact in ALS patients.
CONDITIONS
Brief Title
A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 80 years
- Diagnosis of ALS by revised El Escorial Criteria within 24 months of first symptoms
- Stable dose of existing ALS treatment for at least 28 days
You will not qualify if you...
- Severe systemic infections currently or within two weeks prior to study entry
- Unable or unwilling to give informed consent or follow study requirements
- Use of other investigational treatments within 30 days before screening
- Pregnant or nursing women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 52 weeks
Participants receive the study drug TCD601 (siplizumab) along with the contemporary standard of care regimen to evaluate safety, pharmacokinetics, pharmacodynamics, and disease progression.
Regular visits throughout the 52 weeks as per study protocol
Trial Site Locations
Total: 3 locations
1
Skåne University Hospital Malmö
Malmö, Sweden, 205 02
Actively Recruiting
2
Studieenheten Akademiskt Specialistcentrum
Stockholm, Sweden, 171 77
Actively Recruiting
3
Umeå University Hospital
Umeå, Sweden, 901 85
Actively Recruiting
Research Team
F
Fredrik Juhlin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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