Phase 1 trial of TCD601 terminated: “The Sponsor has decided to terminate study early due to significant enrolment challenge…”
Trial at a glance
- Status
- Terminated
- Phase
- Phase 1
- Intervention
- TCD601 (biological) also known as siplizumab
- Enrolment
- 7 participants (actual)
- Site
- Sweden
- Sponsor
- ITB-Med LLC
- Reason given
The Sponsor has decided to terminate study early due to significant enrolment challenges since restarting the study in Dec 2025. The Sponsor is concerned that the study is not feasible and ultimately the objectives of the study cannot be met.
- Registration
- NCT06453668
Compass reports what the trial registry states. A trial being registered, recruiting or completed is not evidence that a treatment works.
This Phase 1 interventional study tested TCD601 in newly diagnosed adults with ALS. It had sites in Sweden and enrolled seven participants. The registry now lists the study as terminated, with the sponsor citing significant enrolment challenges since restarting in December 2025 and concerns that its objectives could not be met.
Why this matters
The study has stopped, so this line of investigation will not continue in this trial. No results have been posted.
Trial updates
Trial terminated — 17 July 2026
Compass began tracking this trial’s registry record on the date of its first update above. Changes before then are not listed.