| Outcome Measures: |
Primary: To assess the safety and tolerability of ascending doses of TOL101 and the effectiveness of TOL101 to target and downregulate T cells in patients undergoing first renal transplantation, The following safety parameters will be monitored: Adverse events, standard laboratory safety evaluations (hematology and serum chemistries), symptom constellation indicating cytokine release syndrome, serum concentrations of cytokines and nitric oxide, malignancies, CMV viremia, BKV viremia, EBV viremia and other infections, 6 months | Secondary: The effects of ascending doses of TOL101 on CD3+ T lymphocyte numbers and other immune cell subsets, 14 days post-transplant (Part A); 6 months (Part B)|The pharmacokinetic (PK) profile of TOL101 in renal transplant recipients and the exposure-response (PK parameter to CD3+ T lymphocyte numbers) relationship over time, 14 days post-transplant|Biopsy-proven acute organ rejection, 6 months|Graft survival, 6 months|Patient survival, 6 months|Renal function by measured GFR at 6 months post-transplant and urine protein to creatinine ratio at 3 and 6 months post-transplant, 6 months|Delayed graft function, first 7 days post-transplant|Immunogenicity of TOL101 by measurement of anti-TOL101 antibodies, at 14 and 28 days post-transplant|The presence of Donor Specific Antibody at 3 months (Part B only) and 6 months post-transplant, 6 months
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| Locations: |
University of Colorado Denver, Aurora, Colorado, 80045, United States|University of Kentucky, Lexington, Kentucky, 40536, United States|University of Michigan, Ann Arbor, Michigan, 48109, United States|St Barnabas Medical Center, Livingston, New Jersey, 07039, United States|Montefiore Medical Center, Bronx, New York, 10467, United States|Buffalo General Hospital, Buffalo, New York, 14203, United States|Cleveland Clinic Foundation, Cleveland, Ohio, 44195, United States|Medical University of South Carolina, Charleston, South Carolina, 29425, United States|Baylor University Medical Center, Dallas, Texas, 75246, United States|Baylor All Saints, Fort Worth, Texas, 76104, United States|University of Utah, Salt Lake City, Utah, 84132, United States|University of Virginia Health System, Charlottesville, Virginia, 22908, United States
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