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Phase 1 trial of TCD601 terminated: “The Sponsor has decided to terminate study early due to significant enrolment challenge…”

Original source

Phase 1 trial of TCD601 terminated: “The Sponsor has decided to terminate study early due to significant enrolment challenge…”ClinicalTrials.gov · 17 July 2026 (opens in a new tab)

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 terminated17 July 2026

Compass began tracking this trial’s registry record on the date of its first update above. Changes before then are not listed.

Summarised by Compass 30 August 2026 · reported from Sweden

This summary was generated by AI from the source listed above. It is not medical advice, so read the original source for anything that affects your care.

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