NCT06997471 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
| NCT ID | NCT06997471 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Francisco Hernández Oliveros |
| Condition | Solid Organ Transplant Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-06-10 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to evaluate the safety and feasibility of inducing hematopoietic mixed chimerism to promote immune tolerance and potentially reduce the need for lifelong immunosuppression in pediatric and adult patients undergoing solid organ transplantation (SOT), including kidney, lung, and multivisceral transplants. The main questions it aims to answer are: * Is it safe to infuse a naïve T cell-depleted hematopoietic graft along with memory T-lymphocytes after SOT? * Can this approach support immune tolerance and reduce the incidence of rejection and infection without long-term immunosuppression? Participants will: * Undergo a solid organ transplant from a living or deceased donor. * Wait through a stabilization period to ensure resolution of early transplant-related complications. * Receive low-dose preconditioning (TLI and thymic irradiation) to prepare for hematopoietic stem cell transplantation. * Be infused with a graft containing CD34+ progenitor cells, memory T cells (CD45RO+), and no naïve T cells (CD45RA+); in some cases, NK cells may also be included. * Be followed for graft survival, immune tolerance, infection rates, and adverse events through regular clinical and immune monitoring visits.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06997471 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, studying Solid Organ Transplant Complications. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06997471 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06997471 currently recruiting?
Yes, NCT06997471 is actively recruiting participants. Contact the research team at fhernandezo@salud.madrid.org for enrollment information.
Where is the NCT06997471 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT06997471 clinical trial?
NCT06997471 is sponsored by Francisco Hernández Oliveros. The trial plans to enroll 10 participants.