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

NCT ID: NCT04803006

Last Updated: 2025-07-10

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

2023-01-17

Study Completion Date

2030-07-31

Brief Summary

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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

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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

Arm 2

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 first renal transplant from a non-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

Sponsors

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ITB-Med LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tracy Killingsworth

Role: STUDY_DIRECTOR

Nefro Avillion

Locations

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UCSF Connie Frank Transplant Center

San Francisco, California, United States

Site Status

Columbia University Irving Medical Center

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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TCD601A201

Identifier Type: -

Identifier Source: org_study_id

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