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

Phase 2

Active, not recruiting

• Conditions: Kidney Transplantation
• Interventions: Biological: TCD601

• Registration Number: NCT04803006
• Lead Sponsor: ITB-Med LLC

Brief Summary

The purpose of this study is to determine the optimal regimen for the use of siplizumab, a human anti-CD2 antibody, combined with donor bone marrow cells and non-myeloablative conditioning, for tolerance induction in living donor renal transplantation

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: 2023-01-17
• Status Verified: 2024-12
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-07
• Study Completion: 2030-07

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 first renal transplant from a non-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: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm 1	TCD601	TCD601administered with non-myeloablative conditioning and standard of care immunosuppression
Arm 2	TCD601	TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Primary Outcome Measures

Name	Time	Method
The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome	24 months	The proportion of patients off immunosuppression with good safety and tolerability

Secondary Outcome Measures

Name	Time	Method
The incidence of biopsy proven acute rejection, death and graft loss	24 months
The incidence of de novo donor-specific antibody	24 months

Trial Locations

Locations (5)

UCSF Connie Frank Transplant Center; 🇺🇸 San Francisco, California, United States

University of Maryland; 🇺🇸 Baltimore, Maryland, United States

Cooperman Barnabas Medical Center; 🇺🇸 Livingston, New Jersey, United States

NYU Langone; 🇺🇸 New York, New York, United States

Columbia University Irving Medical Center; 🇺🇸 New York, New York, United States