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

Phase 2TerminatedNCT04803006

ITB-Med LLC4 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Transplantation

Interventions

TCD601BIOLOGICAL

Investigational Product

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 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)

Locations (1)

Columbia University Irving Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

The optimal regimen for renal allograft tolerance while minimizing chimeric transition syndrome

The proportion of patients off immunosuppression with good safety and tolerability

Time frame: 24 months

Secondary Outcomes

The incidence of biopsy proven acute rejection, death and graft loss

Time frame: 24 months

The incidence of de novo donor-specific antibody

Time frame: 24 months

Data from ClinicalTrials.gov

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