A Study of TCD601 in the Induction of Tolerance in Renal... | NCT04803058

Studies
A Study of TCD601 in the Induction of Tolerance in Renal Transplantation (PERSPECTIVE)

NCT04803058

Sponsor

ITB-Med LLC

Status

Active, not recruiting

Last Update Posted

Feb 6, 2026Actual

Enrollment

18Estimated

Phase

Phase 2

Conditions

Kidney Transplantation

Interventions

TCD601

Countries

United States
South Korea

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

Official Title

A Safety and Tolerability Study of TCD601 (Siplizumab), a Human Anti-CD2 Antibody, Combined With Donor Bone Marrow Cell Infusion and Non-Myeloablative Conditioning, Including Fludarabine and Cyclophosphamide, for Tolerance Induction in Living Donor Renal Transplantation

Status Module

Record Verification Date

Feb 2026

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

Dec 14, 2022Actual

Primary Completion Date

Mar 2027Estimated

Completion Date

Mar 2030Estimated

First Submitted Date

Mar 14, 2021

First Submission Date that Met QC Criteria

Mar 14, 2021

First Posted Date

Mar 17, 2021Actual

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

Feb 4, 2026

Last Update Posted Date

Feb 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

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 TCD601 can induce allogeneic tolerance in living donor renal 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

18Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	TCD601administered with non-myeloablative conditioning and standard of care immunosuppression	Biological: TCD601

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The safety, tolerability and activity of a Siplizumab-based conditioning regimen to induce renal allograft tolerance	The proportion of patients off immunosuppression with good safety and tolerability	24 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence of biopsy proven acute rejection, death, and graft loss		24 months
The incidence of DSA		24 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key Inclusion Criteria:

Able to understand the study requirements and provide written informed consent before any study assessment is performed
Male or female patients ≥ 18 to 65 years of age
Recipient of a renal transplant from a non-human leukocyte antigen (HLA)-identical but at least haploidentical, ABO compatible living donor

Key Exclusion Criteria:

Women of child-bearing potential, unless willing to comply with the use of highly effective methods of contraception as defined by the protocol
A history of cancer other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
Recipient with anti-HLA donor-specific antibody (DSA)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 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
Tracy Killingsworth	Nefro Avillion	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Mayo Clinic