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

Launched by FRANCISCO HERNÁNDEZ OLIVEROS · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new method to help solid organ transplant recipients, such as those receiving kidneys, lungs, or other organs, have a safer recovery. The goal is to see if infusing a specific type of immune cells, called memory T cells, along with other cells, can help the body accept the new organ without needing long-term medication to suppress the immune system. This could reduce the risk of organ rejection and infections, which are common challenges after a transplant.

To participate, you or your child must be a candidate for a solid organ transplant, and you will need to be in good health overall. This trial is open to children and adults, but there are certain health conditions that would exclude someone from participating, like active infections or severe organ problems. If eligible, participants will receive the transplant, go through a preparation process, and then receive the special cell infusion. Throughout the study, participants will be closely monitored to ensure their safety and the success of the transplant. This trial is not yet recruiting participants, but it represents an exciting step towards improving transplant outcomes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Pediatric patients (\<18 years old) who are candidates to receive intestinal or lung transplantation (before SOT).
• • Pediatric (\<18 years old) or adult patients (≥18 years old) who are either candidates for renal transplantation or have already undergone renal transplantation and remain candidates for subsequent HSCT.
• • Patients who provide informed consent (or their legal guardians in the case of minors) before any study-related procedures.
• • Recipients should have no active infectious disease or other medical condition that would contraindicate the combined transplantation procedure, as determined by the investigational team.
• Exclusion Criteria:
• • Recipients with existing bone marrow disorders or those receiving medications known to adversely affect bone marrow function.
• • Patients with advanced organ dysfunction (hepatic, cardiac, or pulmonary) incompatible with successful combined transplantation.
• • Patients with active or uncontrolled autoimmune conditions that may interfere with transplantation and the induction of chimerism.
• • Patients with known allergies to medications or products required for conditioning or transplantation.
• • Patients with severe psychiatric or cognitive disorders that may interfere with adherence to study instructions or postoperative care.
• • Patients currently enrolled in another clinical trial that could interfere with the outcomes or safety of this study.
• • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
• • Any other condition that, in the opinion if the Investigator, may interfere with the efficacy and/or safety evaluation of the trial.