Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

A randomized controlled study to assess the safety and efficacy and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.

Official Title

A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors

Details

The purpose of this randomized (2:1) controlled study is to assess the safety, efficacy and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation relative to a standard-of-care control immunosuppression regimen of antibody induction, tacrolimus, mycophenolate, and corticosteroids. FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose in kidney transplant recipients who received a non-myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells. This therapy induces or restores patients' immune tolerance by establishing stable donor chimerism in the transplant recipient without the need for life-long immunosuppression.

Keywords

Transplanted Organ Rejection Kidney Transplant Stem cell therapy Anti-rejection medications Living donor kidney transplant Immune tolerance FCR001

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Written informed consent must be obtained, from recipients and donors, before any assessment is performed on the respective subject.
  2. Recipient age ≥18 years.
  3. Donor age ≥18 and ≤60 years
  4. Recipients of a first kidney transplant from a living unrelated or non- human leukocyte antigen (HLA) identical living related donor.
  5. Donor willing to undergo mobilization, apheresis and 12-month safety follow-up. Donor and Recipient: COVID-19 nucleic acid test (NAT) (e.g., SARS-CoV-2 RT-PCR) negative.
  6. Must be willing and able to comply with protocol-required visit schedule and visit requirements.

Recipient and Donor

You CAN'T join if...

  1. Recipient or donor with use of other investigational drugs within 30 days (or within 5 drug half-lives) of signing informed consent.
  2. Recipient or donor with history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  3. Recipient and donor who are identical twins.
  4. Recipient or donor who is a pregnant or nursing (lactating) woman.
  5. Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome) of any organ system (other than localized basal cell carcinoma 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.
  6. Recipient or donor with known bone marrow aplasia.

Recipient-only Exclusion Criteria:

  1. Multi-organ or cell transplant recipient.
  2. Panel reactive antibodies (calculated panel reactive antibody>20% by Flow/Luminex).
  3. Recipient is blood type ABO incompatible or has positive crossmatch (Flow/Luminex) vs. donor.
  4. Presence of donor-specific antibodies (DSA) (positive result) at any time pre-transplant.
  5. Recipient who is human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive.
  6. Recipient with systemic infection, current or within the 2 weeks prior to conditioning; or history of recurrent infection (eg, polycystic liver/kidney disease, unless native kidneys removed at time of transplant).
  7. Recipient with any baseline condition requiring or anticipated will require chronic or intermittent use of systemic steroids or other IS (eg, autoimmune disease, asthma) throughout the course of the study.
  8. Recipient who had a live attenuated vaccine administered within 2 months of planned transplant surgery.
  9. Recipient with a BMI < 18 or > 35 kg/m2.
  10. . Recipient requiring systemic anticoagulation, (eg, for hyper-coagulation disorders, deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted which would preclude renal biopsy.
  11. . Recipient with contraindication to total body irradiation (TBI) according to local radiologist, eg, previous radiation therapy at a dose which would preclude TBI, inadequate pulmonary function.
  12. . Recipient with autologous or allogeneic hematopoietic progenitor cell transplant prior to signing informed consent.
  13. . All recipient women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, who do not agree to using highly effective methods of contraception during dosing of study treatment.
  14. . Sexually active male control recipient must use a condom during intercourse throughout the study and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of drugs via seminal fluid. FRC001 recipient this requirement may be lifted at 6 weeks after MMF and tacrolimus have been discontinued.

Donor-only Exclusion Criteria:

  1. Biologically unrelated female donor transplant to male recipient.
  2. Donor tested positive for Zika virus (ZIKV) infection. Zika infection is excluded by negative nucleic acid testing result on either serum or urine PLUS a negative Zika

IgM. Only donors with the following risk factors must be tested:

  1. Medical diagnosis of ZIKV in the past 6 months.
  2. Residence in, or travel to, an area with an increased risk for ZIKV transmission within the past 6 months.
  3. Sex within the past 6 months with a person who has either of the risk factors listed in items (a) or (b), above.

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Scripps Clinic accepting new patients
    La Jolla California 92037 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Talaris Therapeutics Inc.
ID
NCT03995901
Phase
Phase 3 Research Study
Study Type
Interventional
Participants
Expecting 240 study participants
Last Updated