ALSPhase 1AURORANCT06453668
A Study of TCD601 (Siplizumab) in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients
A Phase 1 study testing TCD601 in people with ALS, run by ITB-Med LLC at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ALS
- What is being tested?
- TCD601
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesSweden
- Study dates
- 16 Apr 2024to 2 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Skåne University Hospital Malmö
Malmö, 205 02
Studieenheten Akademiskt Specialistcentrum
Stockholm, 171 77
Umeå University Hospital
Umeå, 901 85
About this study
Official title: A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)
The purpose of this study is to investigate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of TCD601 (siplizumab) in newly diagnosed adult ALS patients.
Read the detailed description
The purpose of this study is to investigate how safe and tolerable the study drug siplizumab is when given to adult patients with ALS. The study will examine how the drug is distributed in the body and what effects it has on different immune cells in the blood and in the fluid surrounding the motor neurons (cerebrospinal fluid). In addition, the study will monitor the progression of ALS and look for any changes related to the disease that may occur during the study.
- Conditions
- ALS
- Being tested
- TCD601
- Keywords
- Amyotrophic Lateral Sclerosis, Neuroinflammatory
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCD601Biological
Also called siplizumab
Investigational Product
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | TCD601 (siplizumab) administered with the contemporary standard of care regimen. Receives: Biological: TCD601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the safety of TCD601 in adult patients with ALS
Assess the incidence of treatment-emergent Adverse Events [Safety and Tolerability]
Measured: 12 Months
Secondary outcomes (7)
Evaluation of the pharmacokinetics (PK)
Siplizumab concentration over time
Measured: 12 Months
Correlation of ALS disease status with leucocyte phenotypic profiles
The ALS disease status measured by ALSFRS and Kings staging will be compared with the leucocyte phenotypes measured by FACS analysis.
Measured: 12 Months
Evaluation of levels of biomarkers
Neurofilament light chain levels over time
Measured: 12 Months
Length of time from trial entry to tracheostomy / death
The time from study enrollment to patient death or tracheostomy will be measured.
Measured: 12 Months
Assessment of clinically relevant changes in laboratory measurements
Incidence of abnormal laboratory values
Measured: 12 Months
Evaluation of pharmacodynamics (PD) of TCD601
Lymphocyte counts by subset over time
Measured: 12 Months
Assessment of clinically relevant changes in vital signs
Incidence of abnormal vital signs
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start16 Apr 2024
- Primary completion2 Jul 2026
- Study completion2 Jul 2026
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- ITB-Med LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fredrik Julin, Study director, ITB-Med LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453668
- Sponsor's protocol ID
- TCD601H101
- Acronym
- AURORA
- Status last verified
- Jul 2026
- First submitted
- 6 May 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week, Phase 1 Safety, Pharmacokinetic and Pharmacodynamic Trial of Siplizumab in Newly Diagnosed Adult Amyotrophic Lateral Sclerosis (ALS) Patients (AURORA)
- ClinicalTrials.gov ID
- NCT06453668
- Acronym / sponsor ID
- AURORA / TCD601H101
- Conditions
- ALS
- Keywords
- Amyotrophic Lateral Sclerosis, Neuroinflammatory
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- ITB-Med LLCIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 2 Jul 2026 (actual)
- Study completion
- 2 Jul 2026 (actual)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
The purpose of this study is to investigate how safe and tolerable the study drug siplizumab is when given to adult patients with ALS. The study will examine how the drug is distributed in the body and what effects it has on different immune cells in the blood and in the fluid surrounding the motor neurons (cerebrospinal fluid). In addition, the study will monitor the progression of ALS and look for any changes related to the disease that may occur during the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: TCD601TCD601 (siplizumab) administered with the contemporary standard of care regimen. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCD601Also: siplizumabInvestigational Product | Biological | Treatment |
Primary outcome
Evaluation of the safety of TCD601 in adult patients with ALS
Time frame: 12 Months
Assess the incidence of treatment-emergent Adverse Events [Safety and Tolerability]
7 secondary outcomes
Evaluation of the pharmacokinetics (PK)
Time frame: 12 Months
Correlation of ALS disease status with leucocyte phenotypic profiles
Time frame: 12 Months
Evaluation of levels of biomarkers
Time frame: 12 Months
Length of time from trial entry to tracheostomy / death
Time frame: 12 Months
Assessment of clinically relevant changes in laboratory measurements
Time frame: 12 Months
Evaluation of pharmacodynamics (PD) of TCD601
Time frame: 12 Months
Assessment of clinically relevant changes in vital signs
Time frame: 12 Months
Results and safety
The study was stopped early (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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
Related trials for ALS
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacodynamic Exploration of Orelabrutinib in Patients With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Recruiting
Clinical Outcome Assessment for AT & BCI
Spinal Cord Injury, ALS (Amyotrophic Lateral Sclerosis)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredrik Julin study director
ITB-Med LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TCD601 in people with ALS, run by ITB-Med LLC at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the safety of TCD601 in adult patients with ALS (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.