TCD601 (siplizumab) treatment for adults newly diagnosed with ALS
A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)
This trial will test whether TCD601 (siplizumab) is safe and how it behaves in adults recently diagnosed with ALS.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | ITB-Med LLC Industry-sponsored |
| Drugs / interventions | siplizumab |
| Locations | 3 sites (Malmö and 2 other locations) |
| Trial ID | NCT06453668 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial gives TCD601 (siplizumab) to adults with ALS within 24 months of symptom onset to measure safety, tolerability, and how the drug is processed by the body. Investigators will collect blood and cerebrospinal fluid to study pharmacokinetics and pharmacodynamic effects on immune cells. Participants may continue stable background ALS treatments and will be monitored for adverse events and any changes in disease status. The study aims to define safe dosing and biological activity to guide later trials.
Who should consider this trial
Good fit: Adults aged 18–80 with a diagnosis of ALS by the revised El Escorial Criteria within 24 months of first symptoms and on stable ALS treatment for at least 28 days are the intended participants.
Not a fit: People with recent severe systemic infections, pregnant or nursing women, those unable to consent or adhere to visits, or those who recently used other investigational drugs are unlikely to benefit from participation.
Why it matters
Potential benefit: If safe and showing favorable PK/PD and biological effects, this approach could open a path to immune-targeted therapies that might slow ALS progression.
How similar studies have performed: Immunotherapy approaches in ALS have shown mixed results to date, and siplizumab's use in ALS is relatively novel and unproven.
Eligibility criteria
Show full inclusion / exclusion criteria
Key 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.
Where this trial is running
Malmö and 2 other locations
- Skåne University Hospital Malmö — Malmö, Sweden (Recruiting)
- Studieenheten Akademiskt Specialistcentrum — Stockholm, Sweden (Recruiting)
- Umeå University Hospital — Umeå, Sweden (Recruiting)
Study contacts
- Study coordinator: Fredrik Juhlin
- Email: fredrik.juhlin@itb-med.com
- Phone: +46 (0)76 394 9872
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.