Clinical Research Directory
Browse clinical research sites, groups, and studies.
Early Trial of Allogeneic Hematopoietic Stem Cell Transplantation for Patients Who Will Receive a Kidney Transplant From the Same Donor
Sponsor: Alice Bertaina
Summary
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
Key Details
Gender
All
Age Range
1 Year - 30 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2023-01-10
Completion Date
2034-10
Last Updated
2023-07-17
Healthy Volunteers
No
Interventions
Cyclophosphamide 1200 mg/Kg
Cyclophosphamide 1200 mg/Kg will be administered as part of the conditioning regimen A prior to HSCT
Fludarabine
Fludarabine (starting dose 0.5 mg/Kg and then PK guided to reach an AUC of 18-20) will be administered as part of the conditioning regimen prior to HSCT
Cyclophosphamide 100 mg/Kg
Cyclophosphamide 100 mg/Kg will be administered as part of the conditioning regimen B prior to HSCT
Total Body Irradiation
Total Body Irradiation 200 cGy will be administered as part of the conditioning regimen prior to HSCT
ATG
ATG 7.5 mg/Kg will be administered as part of the conditioning regimen prior to HSCT
Rituximab
Rituximab 200 mg/m2 will be administered within 24 hours of the HSCT
Melphalan
Melphalan 100 mg/m2 will be administered as part of the conditioning regimen prior to HSCT
CliniMACS® TCR α/β Reagent Kit and CliniMACS® CD19 System
CliniMACS® TCRαβ-Biotin and CD19 Systems will be used to create the mobilized peripheral blood stem cells (PBSC) from allogeneic donors depleted of TCRαβ+ T cells and CD19+ B cells to be infused into the patient for the HSCT. The target dose for the number of CD34+ HSC infused is \> 10 x 10\^6 cells/Kg recipient weight. The minimum dose is 2 x 10\^6 cells/Kg. There is no upper limit to the dose of CD34+ HSC infused as long as no more than 1 x 10\^5 TCRαβ+ T-cells/Kg are infused. The target dose of TCRαβ+ T cells/Kg is \< 0.50 x 10\^5.
Kidney Transplant
In the presence of donor myeloid engraftment, at least 3 months post-HSCT, with \> 95% donor CD3+ chimerism, in the absence of signs of active aGvHD or cGvHD (moderate or severe), at least 4 weeks off of immunosuppression for any previously occurring acute or chronic GvHD (except single agent treatment of mild cGvHD), and with a BMI \>18.5, ambulatory and active in addition to the eligibility for the standard of care KT criteria, patients will undergo a living donor KT using same donor as HSCT
Locations (1)
Lucile Packard Children's Hospital
Palo Alto, California, United States