Liver TransplantationPhase 2NCT06019507
A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation
A Phase 2 study testing TCD601, Cyclophosphamide and TAC in people with Liver Transplantation, run by ITB-Med LLC at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Transplantation
- What is being tested?
- TCD601, Cyclophosphamide and TAC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 29 Jun 2022to Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to understand the study requirements and provide written informed consent before and study assessment is performed
- Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant
- Male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of MMF
Who cannot join
- Pregnant or nursing (lactating) women
- Subjects with a history of TB or latent TB infection
- Subjects with a history of cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 60 Month, Single-arm, Proof-of-concept Study to Induce Allogeneic Tolerance in Deceased Donor Liver Transplant Recipients Using Siplizumab, an Anti-CD2 Antibody in Combination With Cyclophosphamide and Splenectomy
The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.
- Conditions
- Liver Transplantation
- Being tested
- TCD601, Cyclophosphamide, TAC, MMF, Corticosteroids
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
CyclophosphamideBiological
Conditioning Regimen
TACDrug
Also called Tacrolimus
Immunosuppression Therapy
MMFDrug
Also called Mycophenolate Mofetil
Immunosuppression Therapy
CorticosteroidsDrug
Immunosuppression Therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy Receives: Biological: TCD601; Biological: Cyclophosphamide; Drug: TAC; Drug: MMF; Drug: Corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Liver Transplant Recipients off of immunosuppression Therapy.
Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients
Measured: 30 months
Secondary outcomes (1)
The Incidence of adverse events and serious adverse events
To explore the safety and tolerability of TCD601.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start29 Jun 2022
- Primary completionJun 2026 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver TransplantationStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ITB-Med LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kellie Kennon, BSN, Study director, ITB-MED
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019507
- Sponsor's protocol ID
- TCD601G201
- Status last verified
- Nov 2024
- First submitted
- 25 Aug 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 60 Month, Single-arm, Proof-of-concept Study to Induce Allogeneic Tolerance in Deceased Donor Liver Transplant Recipients Using Siplizumab, an Anti-CD2 Antibody in Combination With Cyclophosphamide and Splenectomy
- ClinicalTrials.gov ID
- NCT06019507
- Acronym / sponsor ID
- TCD601G201
- Conditions
- Liver Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- ITB-Med LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 31 Aug 2023 (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 evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: TCD601, Biological: Cyclophosphamide, Drug: TAC, Drug: MMF, Drug: CorticosteroidsTCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to understand the study requirements and provide written informed consent before and study assessment is performed
- Adult subjects aged 18-70 receiving an ABO compatible deceased donor liver transplant
- Male study subjects willing to maintain barrier contraception (condom) and agree not to father a child until 12 weeks after the last dose of MMF
Key exclusion criteria (3 listed)
- Pregnant or nursing (lactating) women
- Subjects with a history of TB or latent TB infection
- Subjects with a history of cancer
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 | Arm 1 |
| CyclophosphamideConditioning Regimen | Biological | Arm 1 |
| TACAlso: TacrolimusImmunosuppression Therapy | Drug | Arm 1 |
| MMFAlso: Mycophenolate MofetilImmunosuppression Therapy | Drug | Arm 1 |
| CorticosteroidsImmunosuppression Therapy | Drug | Arm 1 |
Primary outcome
Number of Liver Transplant Recipients off of immunosuppression Therapy.
Time frame: 30 months
Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients
1 secondary outcome
The Incidence of adverse events and serious adverse events
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
Related trials for Liver Transplantation
Not yet recruitingObservational study
Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant
Hematopoietic Stem Cell Transplant
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Not yet recruiting
New Biomarkers for Organ Viability Assessment During Hypothermic Machine Perfusion in Liver Transplantation: the Role of Extemporaneous Histological Examination.
Liver Transplantation (LT), Early Allograft Dysfunction
RecruitingPhase 2
Expanding Liver Transplant Immunosuppression Minimization Via Everolimus
Liver Transplant
RecruitingObservational study
Long-term Follow-up (LTFU) Study of Participants in Any iECURE Protocol Using an Investigational Product (IP)
Ornithine Transcarbamylase Deficiency, Ornithine Transcarbamylase Deficiency Disease
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.
Kellie Kennon, BSN study director
ITB-MED
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCD601, Cyclophosphamide and TAC in people with Liver Transplantation, run by ITB-Med LLC at 1 site 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 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Number of Liver Transplant Recipients off of immunosuppression Therapy. (time frame: 30 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 27 Nov 2024.