A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients

NCT01649388 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: FCR001B2201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.

Conditions

Kidney Transplantation

Keywords

Selective allograft tolerance; Stem cell therapy; Living donor kidney transplant; Immune tolerance; Durable chimerism; Immunosuppression; Immunosuppressive medications; Organ transplant rejection; Anti-rejection medications

Outcome Measures

Primary Outcomes (1)

• Proportion of FCR recipients (FCR-R) who are free from immunosuppression (IS), without biopsy-proven acute rejection (BPAR), at 24 months post-FCR001 infusion

  From infusion to 24 months

Secondary Outcomes (15)

• Change in renal function (estimated Glomerular Filtration Rate [eGFR] by Modification of Diet in Renal Disease [MDRD4]) from baseline (Day 1, prior to FCR001 infusion) to Month 24 in FCR recipients

  From Day 1 prior to infusion to 24 months

• Renal allograft function (eGFR by MDRD4)

  From infusion to 24 months and 60 months

• Change in renal allograft function over time by MDRD4

  From infusion to 24 months and 60 months

• Renal allograft function (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

  From infusion to 24 months and 60 months

• Change in renal allograft function over time by CKD-EPI

  From infusion to 24 months and 60 months

Study Arms (1)

FCR001

EXPERIMENTAL

Recipients 3-12 months post-living kidney transplantation undergo non-myeloablative conditioning followed by infusion of an enriched hematopoietic stem cell product derived from the same living donor's peripheral blood stem cells

Biological: FCR001

Interventions

FCR001 BIOLOGICAL

Enriched hematopoietic stem cell infusion

FCR001

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recipient age ≥18 years old.
• Donor age ≥18 and ≤60 years old at the time of signing informed consent.
• Recipient of a first kidney transplant from a living donor 3-12 months prior to signing informed consent.
• Stable renal allograft function ≥60 mL/min/1.73m\^2 prior to screening (defined as \<25% decrease in eGFR (by Modification of Diet in Renal Disease formula \[MDRD4\]) between the last 2 consecutive visits and per investigator judgment).
• Donor between 3 weeks and 12 months after kidney donation, willing to undergo mobilization, apheresis, and 12-month safety follow-up.

You may not qualify if:

• Donor/recipient crossmatch positive at time of living donor kidney transplantation.
• Recipient or donor with use of other investigational drugs within 30 days (or within 5 drug half-lives) of signing informed consent.
• Recipient or donor with history of hypersensitivity to any of the study drugs or drugs of similar chemical classes.
• Recipient and donor who are identical twins.
• Pregnant or nursing (lactating) woman.
• Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome, monoclonal gammopathy of renal significance \[MGRS\], monoclonal gammopathy of unknown significant \[MGUS\]) of any organ system (other than localized excised non-melanomatous lesions of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
• Recipient or donor with known bone marrow aplasia.
• Multi-organ or cell transplant recipient.
• Blood type ABO incompatible with donor.
• Positive donor-specific antibody (DSA) at any time pre- or post-transplant (to be confirmed within 30 days prior to FCR001 infusion).
• Panel Reactive Antibodies (PRA) \>80% at the time of living donor kidney transplantation.
• Induction with alemtuzumab at the time of living donor kidney transplantation.
• History of acute rejection (biopsy-proven or suspected and treated) or recurrent kidney disease following living donor kidney transplantation.
• Findings consistent with acute rejection or recurrent disease on the Screening biopsy.
• Demonstrated intolerance to maintenance immunosuppression with tacrolimus and MMF or MPS.

Sponsors & Collaborators

• Talaris Therapeutics Inc.: lead

Study Sites (3)

Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: approximately 15 Donor/Recipient pairs

Study Record Dates

• First Submitted: June 29, 2012
• First Posted: July 25, 2012
• Study Start: October 15, 2012
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 2, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)