Phase I Trial on the Safety of Delayed Infusion of a Naïve T Cell-Depleted Hematopoietic Graft With Memory T Cells in Solid Organ Transplant Recipients

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Solid Organ Transplant ComplicationsSolid Organ Transplant RecipientsSolid Organ Transplant Rejection
Interventions
BIOLOGICAL

Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytes

"Infusion Schedule~1. Primary Infusion: the enriched graft, containing the CD34+ progenitors and depleted naïve T cells, will be infused after the patient has undergone conditioning therapy.~2. In the case of haploidentical donors, an additional NK cell infusion will be administered whenever possible around day 7 post-transplant from a non-mobilized apheresis collection, aiming to enhance graft tolerance and prevente HHV6 disease.~3. Post-Transplant Memory T cell Infusions: beginning on days 15 and 30, and then administered monthly up to a maximum of one year or until the supply is depleted, memory T cells will be infused.~Conditioning Regimen~Prior to HSCT, all patients will undergo a low-intensity conditioning regimen designed to allow engraftment of the donor cells while minimizing toxicity:~1. Total Lymphoid Irradiation (TLI): 8 Gy of total lymphoid irradiation will be administered.~2. Fludarabine: a total dose of 120 mg/m², spread over 4 days (-6 to -3 before transplant), will serv"

All Listed Sponsors
lead

Francisco Hernández Oliveros

OTHER