Status and phase
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About
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients.
Enrolled subjects will be randomized to one of 2 study arms:
Arm 1 subjects will receive standard of care immunosuppression
Arm 2 subjects will receive initial standard of care (SOC) immunosuppression and a single infusion of TRK-001. Three months after the transplant, Arm 2 subjects may be able to begin reducing their immunosuppression medication to a 1-drug regimen.
The primary outcome measures of trial are to evaluate several components indicating immunologic problems with the transplanted organ at 1-year post-transplant and to evaluate the ability for the study subjects given TRK-001 to wean to a 1-drug immunosuppression regimen.
All enrolled subjects will be followed for 5 years post-transplant.
Full description
This is a prospective, multi-national, multi-center, open-label, randomized Phase 2 trial to determine the safety and efficacy of administering autologous expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients.
All subjects will be followed for 5 years post-transplant, comprising of a 2-year post-transplant follow-up period and a 3-year surveillance period.
Subjects with end-stage renal disease undergoing a living donor kidney transplant will be enrolled into the trial as follows:
Arm 1 SOC: Standard of care immunosuppression (N=14)
Arm 2 TRACT/MONO: TRK-001 and initial SOC immunosuppression weaned to monotherapy (N=20)
At Month 3 post-transplant, Arm 2 subjects will be further randomized prior to weaning to either mTOR or CNI monotherapy as follows:
Arm 2A: TRACT/MONO mTOR (N=10) or Arm 2B: TRACT/MONO CNI (N=10)
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Males or females aged 18-65 years as of the date of informed consent who will undergo a single organ, living donor kidney transplant.
Donor aged 18-65 years as of the date of organ donation. A certain degree of HLA matching between the donor and the recipient is not required.
Blood type compatibility between recipient and donor must be established as follows.
Recipient A to Donor A or O; Recipient B to Donor B or O; Recipient AB to Donor A, B, AB, or O; Recipient O to Donor O.
No prior organ transplant of any kind.
Women of childbearing potential must agree to use a medically acceptable method of contraception throughout the trial. A list of the medically acceptable methods of contraception are listed in the informed consent document.
Male patients must agree to use birth control following the initiation of standard-of-care immunosuppression and for a minimum of 6 months following kidney transplant.
Subjects (recipients) must be able to understand the consent form and give written informed consent prior to any trial procedure.
If donor informed consent is required by IRB/IEC, donor must be able to understand the consent form and give written informed consent prior to any trial procedure. Note: Donor informed consent is required for donors participating in the research assay collections.
Exclusion Criteria Based on SOC Pre-Transplant Evaluation
Known sensitivity or contraindication to thymoglobulin, everolimus, sirolimus, or tacrolimus or other immunosuppression medication prescribed.
Subjects with an active infection considered clinically significant by an investigator that has not resolved prior to transplant.
Subjects with a positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
Subjects with PRA >80% per SOC pre-transplant assessment. PRA must be repeated prior to transplant if patient receives a blood product transfusion after the initial assessment.
Subjects with current or historic donor specific antibodies.
Body Mass Index (BMI) of < 16 kg/m2 or > 38 kg/m2 per SOC pre-transplant evaluation.
Subjects who are pregnant or nursing mothers.
Subjects whose life expectancy is severely limited by diseases other than renal disease, per judgement of an investigator.
Ongoing active drug or alcohol substance abuse, per judgement of an investigator.
Major ongoing psychiatric illness or recent history of noncompliance with current medical therapy, per judgement of an investigator.
Significant cardiovascular disease (e.g.):
Subjects who require use of chronic anticoagulation medications. Use of anti-platelet medications will be allowed in absence of a documented arrhythmia.
Malignancy within 3 years, excluding non-melanoma skin cancers such as basal cell carcinoma and squamous cell carcinoma.
Serologic evidence of active infection with HCV, HIV or HBV per SOC pre-transplant evaluation.
Subjects with a total white blood cell count < 4,000/mm3; platelet count < 50,000/mm3; triglyceride > 400 mg/dL; total cholesterol > 300 mg/dL, prothrombin time <8.4 seconds or >15.7 seconds, activated partial thromboplastin time <21.6 seconds or >42.3 seconds, fibrinogen <177 mg/dL or >598 mg/dL, and INR <0.64 or >1.4.
Subjects with underlying renal disease etiologies with high risk of disease recurrence such as primary focal segmental glomerulosclerosis and others per investigator discretion.
Subjects requiring the use of chronic immunosuppressive medication to control an underlying renal disease, or a disease with extrarenal manifestations (i.e., inflammatory bowel disease). Subjects requiring chronic or intermittent use of inhaled corticosteroids for respiratory conditions will be allowed.
Diabetic subjects with an HbA1c of >8%.
Exclusion Criteria Prior to Leukapheresis (Arm 2)
Exclusion Criteria Prior to TRACT Cellular Product Infusion (Arm 2)
Primary purpose
Allocation
Interventional model
Masking
34 participants in 3 patient groups
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Central trial contact
Susan B Murray; Erwin Teng
Data sourced from clinicaltrials.gov
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