A Study of TCD601 in the Induction of Tolerance in de Nov... | NCT06019507

Studies
A Study of TCD601 in the Induction of Tolerance in de Novo Liver Transplantation

NCT06019507

Sponsor

ITB-Med LLC

Status

Active, not recruiting

Last Update Posted

Nov 27, 2024Actual

Enrollment

12Estimated

Phase

Phase 2

Conditions

Liver Transplantation

Interventions

TCD601
Cyclophosphamide
TAC
MMF
Corticosteroids

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 29, 2022Actual

Primary Completion Date

Jun 2026Estimated

Completion Date

Jun 2029Estimated

First Submitted Date

Aug 25, 2023

First Submission Date that Met QC Criteria

Aug 25, 2023

First Posted Date

Aug 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 25, 2024

Last Update Posted Date

Nov 27, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate if treatment with a siplizumab-based regimen can induce allogeneic tolerance in liver transplant recipients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	TCD601administered after liver transplant with splenectomy with cyclophosphamide and immunosuppression therapy	Biological: TCD601 Biological: Cyclophosphamide Drug: TAC Drug: MMF Drug: Corticosteroids

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TCD601	Biological	Investigational Product	Arm 1	siplizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Liver Transplant Recipients off of immunosuppression Therapy.	Determine if treatment with siplizumab can induce allogeneic tolerance in liver transplant recipients	30 months

Secondary Outcomes

Measure	Description	Time Frame
The Incidence of adverse events and serious adverse events	To explore the safety and tolerability of TCD601.	30 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant or nursing (lactating) women
Subjects with a history of TB or latent TB infection
Subjects with a history of cancer

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kellie Kennon, BSN	ITB-MED	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karolinska University Hospital		Stockholm	Huddinge		Sweden

Intervention Browse Module

MeSH Terms

ID	Term
C544394	siplizumab
D003520	Cyclophosphamide
D016559	Tacrolimus
D009173	Mycophenolic Acid
D000305	Adrenal Cortex Hormones

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Browse Leaves

Not provided

Browse Branches

Not provided