Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor


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Trial ID: NCT05508009


This is a single center, non-randomized, non-controlled open-label phase 1b/2a trial of performing sequential αβdepleted-HSCT and KT in patients requiring KT to prevent kidney rejection post-KT, in the absence of any post-KT immunosuppression, to abrogate the need for lifelong immunosuppression, the risk of chronic rejection and, ultimately, the need for repeated transplantation.

Official Title

Phase 1b/2a Trial of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) From an HLA-partially Matched Related or Unrelated Donor After TCRαβ+ T-cell/CD19+ B-cell Depletion for Patients Who Will Receive a Kidney Transplant (KT) From the Same HSCT/KT Donor


Inclusion Criteria:

   - Anticipated need for kidney transplant due to:

   a. Underlying genetic/immunologic disease the following conditions i. SIOD ii. FSGS
   iii. Cystinosis iv. SLE v. Membranoproliferative glomerulonephritis vi. Renal
   vasculitis characterized by positivity of the presence of ANCA vii. Other genetic
   diseases leading to kidney disease requiring KT Or b. Patients who have rejected a
   previous KT regardless of the underlying disease

   - Chronic kidney disease (CKD) stage 3 or greater

   - Steroids < 0.5 mg/Kg/day

   - The donor and recipient must be identical, as determined by high resolution typing, at
   least one allele of each of the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DQB1
   and HLA-DRB1

   - Lansky/Karnofsky score > 50; the Karnofsky Scale will be used in subjects ≥ 16 years
   of age, and the Lansky Scale will be used for those < 16 years of age.

   - Able to give informed consent or have an LAR available to provide consent

   - Male and female subjects of childbearing potential must agree to use an effective
   means of birth control to avoid pregnancy throughout the transplant procedure, while
   on immunosuppression, and if the subject experiences any cGvHD

Exclusion Criteria:

   - Pregnant or lactating females.

   - Greater than Grade II aGvHD or severe, unmanaged extensive cGvHD due to a previous
   allograft at the time of inclusion

   - Dysfunction of liver (ALT/AST > 10 times upper normal value, or direct bilirubin > 3
   times upper normal value), unmanageable dysfunction of renal function while undergoing

   - Severe cardiovascular disease at the time of evaluation unresponsive to nutritional
   and dialytic support (left ventricular ejection fraction < 40%), or clinical or
   echocardiographic evidence of severe diastolic dysfunction

   - Current active infectious disease. Human immunodeficiency virus (HIV)-infected
   patients on effective anti-retroviral therapy with undetectable viral load within 6
   months are eligible for this trial. For patients with evidence of chronic hepatitis B
   virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy,
   if indicated. Patients with a history of hepatitis C virus (HCV) infection must have
   been treated and cured. Patients with HCV infection who are currently on treatment are
   eligible if they have an undetectable HCV viral load.

   - Serious concurrent uncontrolled medical disorders except for primary disease leading
   to chronic kidney disease

   - Lack of patient/parent/guardian informed consent

   - Any severe concurrent disease which, in the judgement of the investigator would place
   the patient at increased risk during participation in the study


drug: Cyclophosphamide 1200 mg/Kg

drug: Fludarabine

drug: Cyclophosphamide 100 mg/Kg

radiation: Total Body Irradiation

drug: ATG

drug: Rituximab

drug: Melphalan

device: CliniMACS® TCR α/β Reagent Kit and CliniMACS® CD19 System

procedure: Kidney Transplant


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
SCGT Clinical Trials Program