Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

• ClinicalTrials.gov Identifier: NCT00497926
• Recruitment Status: Terminated
• First Posted: July 9, 2007
• Last Update Posted: October 11, 2023
• Sponsor: Talaris Therapeutics Inc.
• Collaborators: Northwestern University; Regenerex, LLC; Duke University
• Information provided by (Responsible Party): Talaris Therapeutics Inc.

Tracking Information

• First Submitted Date: July 6, 2007
• First Posted Date: July 9, 2007
• Last Update Posted Date: October 11, 2023
• Actual Study Start Date: March 2008
• Actual Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 8, 2021): Enriched Hematopoietic Stem Cell Engraftment [ Time Frame: One month to three years ]
• Original Primary Outcome Measures (submitted: July 6, 2007): Bone marrow engraftment/chimerism
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures (submitted: July 6, 2007): Tolerance induction
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
• Official Title: Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion
• Brief Summary: An open-label study to assess the safety, efficacy, and tolerance of FCRx cell therapy in adult recipients within 12 months after kidney transplantation from a living donor.
• Detailed Description: Research study which involves the use of a combination of an Enriched Hematopoietic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow the body to develop "tolerance" to the transplanted kidney. Tolerance means that the body would see the transplanted kidney as part of the patient and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Kidney Failure

Intervention

Biological: Enriched Hematopoietic Stem Cell Infusion

Enriched Hematopoietic Stem Cell Infusion

Study Arms

Experimental: Living Kidney Allograft

Recipients with the need for a living kidney allograft are treated with an enriched hematopoietic stem cell infusion from the same living donor

Intervention: Biological: Enriched Hematopoietic Stem Cell Infusion

Publications *

• Gallon L, Mathew JM, Bontha SV, Dumur CI, Dalal P, Nadimpalli L, Maluf DG, Shetty AA, Ildstad ST, Leventhal JR, Mas VR. Intragraft Molecular Pathways Associated with Tolerance Induction in Renal Transplantation. J Am Soc Nephrol. 2018 Feb;29(2):423-433. doi: 10.1681/ASN.2017030348. Epub 2017 Nov 30.
• Leventhal JR, Elliott MJ, Yolcu ES, Bozulic LD, Tollerud DJ, Mathew JM, Konieczna I, Ison MG, Galvin J, Mehta J, Badder MD, Abecassis MM, Miller J, Gallon L, Ildstad ST. Immune reconstitution/immunocompetence in recipients of kidney plus hematopoietic stem/facilitating cell transplants. Transplantation. 2015 Feb;99(2):288-98. doi: 10.1097/TP.0000000000000605.

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 10, 2023): 37
• Original Estimated Enrollment (submitted: July 6, 2007): 30
• Actual Study Completion Date: April 2023
• Actual Primary Completion Date: March 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient must be between the ages of 18 and 65 years and meet the institution's criteria for renal transplantation for end-organ failure
• Meets the transplant criteria by the study site and both the recipient and donor have been accepted as candidates for standard of care living kidney donation and transplantation
• Patient is receiving a renal transplant only
• The crossmatch is negative between donor and recipient. An initial crossmatch will be performed prior to stem cell mobilization to determine if subject can proceed with the apheresis.
• Potential recipients who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving Granulocyte colony-stimulating factor (G-CSF) and agree to use reliable contraception for 1 year following FCRx infusion
• Potential donors who are women of child bearing potential must have a negative pregnancy test (urine test is acceptable) within 48 hours prior to receiving G-CSF
• No evidence of donor-specific antibody presently or historically
• Panel Reactive Antibody (PRA) less than or equal to 20

Note: The subjects do not need to be local residents in order to be eligible for this trial, but must be willing to reside in the area, or within a four-hour drive, for the first month of the protocol so that they can be monitored closely in the early post-transplant period.

Exclusion Criteria:

• Clinically active bacterial, fungal, viral or parasitic infection
• Pregnancy
• Clinical or serologic evidence of viral infection which would preclude the recipient from receiving a kidney transplant or FCRx infusion
• Previous radiation therapy at a dose which would preclude Total Body Irradiation (TBI)
• Positive crossmatch between donor and recipient
• Evidence for immunologic memory against donor
• Body Mass Index (BMI) >35 or <18
• Positive serologies for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), human immunodeficiency virus (HIV)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00497926
• Other Study ID Numbers: FCR001A2201
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Talaris Therapeutics Inc.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Talaris Therapeutics Inc.
• Original Study Sponsor: University of Louisville

Collaborators

• Northwestern University
• Regenerex, LLC
• Duke University

Investigators

• Study Director: Ken Abrams, MD; Talaris Therapeutics

• PRS Account: Talaris Therapeutics Inc.
• Verification Date: October 2023