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

Phase 2

Active, not recruiting

• Conditions: Kidney Transplantation
• Interventions: Biological: TCD601

• Registration Number: NCT04803058
• Lead Sponsor: ITB-Med LLC

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 available

Study Timeline

• Study First Submitted: 2021-03-14
• Study First Submitted QC: 2021-03-14
• Study First Posted: 2021-03-17
• Study Start: 2022-12-14
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	TCD601	TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Incidence of biopsy proven acute rejection, death, and graft loss	24 months
The incidence of DSA	24 months

Trial Locations

Locations (6)

Samsung Medical University; 🇰🇷 Seoul, Korea, Republic of

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Weill Cornell; 🇺🇸 New York, New York, United States