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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-14

Study Completion Date

2030-03-31

Brief Summary

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The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

TCD601administered with non-myeloablative conditioning and standard of care immunosuppression

Group Type EXPERIMENTAL

TCD601

Intervention Type BIOLOGICAL

Investigational Product

Interventions

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TCD601

Investigational Product

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No