Clinical trial
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
Name
FCR001A2301
Description
A randomized controlled study to evaluate the safety, efficacy, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.
Trial arms
Trial start
2019-10-25
Estimated PCD
2023-02-16
Trial end
2023-02-16
Status
Terminated
Phase
Early phase I
Treatment
FCR001
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose with a non- myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells.
Arms:
FCR001
Other names:
Cell based therapy, Allogeneic stem cell transplant
Size
15
Primary endpoint
Proportion of FCR001 recipients who are free from immunosuppression (IS), without biopsy proven acute rejection (BPAR) at 24 months post-transplant
24 months post-transplant
Eligibility criteria
Main Inclusion Criteria:
* Recipient age ≥18 years.
* Donor age ≥18 and ≤60 years at time of signing informed consent.
* Recipients of a first or second living donor kidney transplant
* Donor willing to undergo mobilization, apheresis and 12-month safety follow-up and meet all local standard eligibility criteria to donate stem cells for allogeneic transplantation.
* Recipient meets all local standard eligibility criteria for allogeneic stem cell transplant.
* Donors must be deemed eligible as per the requirements of 21CFR1271.
Main Recipient and Donor Exclusion Criteria:
* Recipient and donor who are identical twins.
* Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome, monoclonal gammopathy of renal significance \[MGRS\], monoclonal gammopathy of unknown significance \[MGUS\]) 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.
* Recipient or donor with known bone marrow aplasia.
Main Recipient-only Exclusion Criteria:
* Multi-organ or stem cell transplant recipient.
* Calculated panel reactive antibodies \>80%.
* Recipient is blood type ABO incompatible with donor.
* Presence of donor-specific antibodies (DSA) (positive result) at any time pre-transplant.
* Recipient who is human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive.
* 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.
* Recipient with a BMI \< 18 or \> 35 kg/m2.
* Recipient requiring systemic anticoagulation, (eg, for hyper-coagulation disorders, deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted which would preclude renal biopsy.
Main Donor-only Exclusion Criteria:
* Biologically unrelated (i.e., no genetic relationship) female donor transplant to male recipient.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}
Updated at
2023-03-03
1 organization
Organization
Talaris Therapeutics