A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
Phase 1
Active, not recruiting
- Conditions
- ALS
- Interventions
- Biological: TCD601
- Registration Number
- NCT06453668
- Lead Sponsor
- ITB-Med LLC
- Brief Summary
The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
- Male or female patients ≥ 18 to 80 years of age.
- Diagnosis of ALS by revised El Escorial Criteria, at study entry within 24 months of first symptoms.
- Patients on existing ALS treatment must have been on a stable dose for 28 days.
Key
Exclusion Criteria
- Patient with severe systemic infections, current or within the two weeks prior to randomization.
- Subjects who, in the opinion of the investigator, are not capable of giving informed consent for the study or who are unable or unwilling to adhere to the study requirements outlined in the protocol.
- Use of other investigational products or treatment in another investigational drug study within 30 days of screening
- Pregnant or nursing (lactating) women.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment TCD601 TCD601 (siplizumab) administered with the contemporary standard of care regimen.
- Primary Outcome Measures
Name Time Method Evaluation of the safety of TCD601 in adult patients with ALS 12 Months Assess the incidence of treatment-emergent Adverse Events \[Safety and Tolerability\]
- Secondary Outcome Measures
Name Time Method Correlation of ALS disease status with leucocyte phenotypic profiles 12 Months Assessment of clinically relevant changes in laboratory measurements 12 Months Incidence of abnormal laboratory values
Evaluation of pharmacodynamics (PD) of TCD601 12 Months Lymphocyte counts by subset over time
Length of time from trial entry to tracheostomy / death 12 Months Evaluation of the pharmacokinetics (PK) 12 Months Siplizumab concentration over time
Evaluation of levels of biomarkers 12 Months Neurofilament light chain levels over time
Assessment of clinically relevant changes in vital signs 12 Months Incidence of abnormal vital signs
Trial Locations
- Locations (3)
Umeå University Hospital
🇸🇪Umeå, Sweden
Skåne University Hospital Malmö
🇸🇪Malmö, Sweden
Studieenheten Akademiskt Specialistcentrum
🇸🇪Stockholm, Sweden