Solid Organ Transplant ComplicationsPhase 1DUALGRAFTNCT06997471
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
A Phase 1 study testing Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytes in people with Solid Organ Transplant Complications and Solid Organ Transplant Recipients, run by Francisco Hernández Oliveros at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Solid Organ Transplant Complications, Solid Organ Transplant Recipients, Solid Organ Transplant Rejection
- What is being tested?
- Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytes
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2025to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
La Paz University Hospital
Madrid, Madrid, 28046
Javier Guijarro, MD, +34 608427004, franciscojavier.guijarro@salud.madrid.org
About this study
Official title: A Phase I, Single-Center, Open-Label Trial to Assess the Safety and Tolerability of Delayed Infusion of a Naïve T Cell Depleted Hematopoietic Graft and Memory T-lymphocytes in Recipients of Solid Organ Transplantation
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:
Read more
- 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.
Read the detailed description
This clinical trial is exploring a new way to help patients who receive a solid organ transplant-such as a kidney, lung, or intestine-live longer and healthier lives with fewer side effects from medication. Today, most transplant recipients must take strong immune-suppressing drugs every day to prevent their bodies from rejecting the new organ. While these drugs are essential, they can lead to serious complications over time, such as infections, and even damage to the transplanted organ itself.
The goal of this study is to test a promising strategy that may help the body naturally accept the transplanted organ, reducing or potentially eliminating the need for long-term immunosuppressive drugs. This approach involves a technique called mixed hematopoietic chimerism, which means that the patient's body receives a mix of immune cells from both themselves and the organ donor. When successful, this blend of immune systems can lead to immune tolerance, allowing the transplanted organ to function without being attacked by the patient's immune system.
This is a Phase I, single-center, open-label clinical trial, which means it is an early-stage study focused primarily on evaluating safety. The trial will enroll 10 patients who are either scheduled to receive a solid organ transplant (SOT) or have recently undergone one, depending on the type of organ and donor availability.
After a transplant, each patient must go through a stabilization period, allowing time for any immediate post-surgical complications to improve. Once stabilized, the patient will receive a specially prepared infusion of blood-forming (hematopoietic) stem cells from their organ donor. This process is known as hematopoietic stem cell transplantation (HSCT).
Before this infusion, patients will undergo low-dose preconditioning using total lymphoid irradiation (TLI) and thymic irradiation. These treatments prepare the body to accept the donor's cells without causing major immune damage, and they aim to lower the risk of complications like graft-versus-host disease (GVHD)-a serious condition where donor immune cells attack the patient's tissues.
The infused cell product is carefully designed:
- It includes CD34+ blood stem cells, which help rebuild the patient's immune and blood systems.
- It removes "naïve" T cells (CD45RA+), which are known to cause GVHD.
- It includes "memory" T cells (CD45RO+), which support immune recovery and protection against infections.
In some cases, natural killer cells CD56+ may also be included to help protect against viruses and support tolerance-especially when the donor is haploidentical.
The way the cells are collected depends on whether the donor is living or deceased. For living donors, peripheral blood stem cells are collected. For deceased donors, the bone marrow is used.
This trial is based on encouraging results from earlier studies and aims to show that this strategy is safe and feasible. If successful, the benefits could be wide-ranging:
- Less dependence on lifelong immunosuppressive medications
- Lower risk of chronic rejection of the transplanted organ
- Fewer life-threatening infections
- Improved quality of life, especially for children and young adults
- Increased availability of transplantable organs by improving outcomes and reducing re-transplantation needs
- Lower healthcare costs due to fewer complications, hospitalizations, and medications
The study will also track how well the patient's body accepts the transplanted organ over time and whether true immune tolerance is achieved. This will be monitored by looking at immune markers in the blood and through regular clinical follow-ups.
This approach could be especially helpful for pediatric patients, who face unique challenges, such as difficulty adhering to lifelong medication plans and a higher risk of needing multiple transplants. It may also help adult patients at high risk of rejection, or those who have already had complications with previous transplants.
- Conditions
- Solid Organ Transplant Complications, Solid Organ Transplant Recipients, Solid Organ Transplant Rejection
- Being tested
- Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytesBiological
Infusion Schedule
- Primary Infusion: the enriched graft, containing the CD34+ progenitors and depleted naïve T cells, will be infused after the patient has undergone conditioning therapy.
- 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.
- 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:
- Total Lymphoid Irradiation (TLI): 8 Gy of total lymphoid irradiation will be administered.
- Fludarabine: a total dose of 120 mg/m², spread over 4 days (-6 to -3 before transplant), will serv
| Study group | Role | What they receive |
|---|---|---|
| HSCT using a graft enriched in CD34+ hematopoietic progenitor cells | Experimental | The study intervention involves a HSCT using a graft enriched in CD34+ hematopoietic progenitor cells. This graft will be specifically engineered through depletion of naïve T-lymphocytes (CD45RA+) and patients will be supplemented with memory lymphocytes to support immune reconstitution and promote tolerance. The source of the hematopoietic stem cells (HSCs) will vary depending on whether the donor is a living related donor (HLA-identical or haploidentical) or a deceased donor.
Graft Composition and Cell Doses
* CD34+ cells: < 1 x 107/kg will be intravenously infused as the primary source of hematopoietic progenitors.
* Memory T-lymphocytes (CD45RO+): < 3 x 107/kg will be administered. Naïve T-lymphocytes (CD45RA+) remaining in the memory fraction will always be <1 x 104/kg, to minimize the risk of GVHD while supporting immune surveillance.
* Only in haploidentical participants: NK cells (CD56+): < 5 x 107/kg to promote graft tolerance and target residual malignant cells. Receives: Biological: Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events related to the investigational intervention.
Safety and tolerability will be evaluated based on the incidence, nature and and severity of adverse events during study period. (clinical and laboratory).
Measured: From enrollment to end of follow-up at 2 years after cell therapy administration
Secondary outcomes (14)
Feasibility of cell collection, processing and administration.
- Proportion (%) of participants in which we are able to obtain naïve T cell depleted graft and memory T cells, from alive and deceased donors.
- Prorportion (%) of participants in which we are able to obtain naïve T cell depleted graft and memory T cells from deceased donors.
- Proportion (%) of patients who are able to proceed to haematopoietic stem cell therapy within 3 months following solid organ transplantation.
Measured: From enrollment to 3 months after solid organ transplantation
Mixed hematopoietic chimerism measurement.
Proportion (%) of patients presenting mixed hematopoietic chimerism ≥ 100 days, macrochimerism (>5%) ≥ 100 days, macrochimerism ≥ 30 days and microchimerism (< 5%) ≥ 30 days.
Measured: From therapy administration to 30 days and 100 days after investigational therapy administration
Donor-Specific T Cell Clone Depletion
Proportion (%) of patients demonstrating donor's alloreactive clones depletion by high resolution TCR sequencing one year post haematopoietic stem cell therapy and thereafter.
Measured: One year post haematopoietic stem cell therapy and thereafter.
Organ Rejection Rate
Proportion (%) of patients experiencing organ rejection 1 year after investigational therapy administration.
Measured: From investigational therapy administration to 1 year after
Graft Survival and Failure Rates
Survival rate of grafts, rates of graft failure or complications.
Measured: From enrollment to end of follow-up at 2 years after cell therapy administration
occurence of GVHD in patients receiving delayed infusion of the investigational celular therapy after solid organ transplantation.
Proportion (%) of patients presenting GVHD, GVHD grade 1 and GVHD garde >1
Measured: From enrollment to end of follow-up at 2 years after cell therapy administration
Occurrence of infections in patients receiving delayed infusion of the investigational celular therapy after solid organ transplantation.
Proportion (%) of patients experiencing sepsis or requiring intensive care due to an investigational treatment related adverse event, of viral reactivations/infections, fungal disease, and bacterial infections after investigational treatment initiation.
Measured: From enrollment to end of follow-up at 2 years after cell therapy administration
Immune reconstitution in patients receiving delayed infusion of the investigational celular therapy after solid organ transplantation
Proportion (%) of patients with CD4+ count >200 cells/μL on day 100 post haematopoietic stem cell therapy.
Measured: Day 100 post haematopoietic stem cell therapy.
Immune reconstitution in patients receiving investigational cell therapy
Proportion (%) of patients with Treg percentage > 10% at any point after haematopoietic stem cell therapy.
Measured: From enrollment to end of follow-up at 2 years after cell therapy administration
Development of immune tolerance in transplant recipients
Proportion (%) of patients demonstrating donor's alloreactive clones depletion by high resolution TCR sequencing and proportion (%) of patients experiencing organ rejection one year post haematopoietic stem cell therapy and thereafter.
Measured: One-year post haematopoietic stem cell therapy and thereafter.
Recipient's laboratory hyporesponsiveness towards the graft
Proportion (%) of patients with donor's hyporesponsiveness in Mixed Lymphocyte Reaction (MLR) one-year post haematopoietic stem cell therapy and thereafter.
Measured: One-year post haematopoietic stem cell therapy and thereafter.
Recipient's competence against third party donors
Proportion (%) of patients with third party response in Mixed Lymphocyte Reaction (MLR) one-year post haematopoietic stem cell therapy and thereafter.
Measured: One-year post haematopoietic stem cell therapy and thereafter.
Recipient's competence against virus
Proportion (%) of patients with competent viral immune response in functional tests one-year post haematopoietic stem cell therapy and thereafter.
Measured: One-year post haematopoietic stem cell therapy and thereafter.
Mortality after investigational therapy adminitration.
Proportion (%) of patients alive up to 1 year after investigational therapy administration.
Measured: From enrollment to one year after investigational therapy administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start10 Jun 2025
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid Organ Transplant ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single-center, open-label clinical trial. Its primary goal is to evaluate the safety of inducing hematopoietic mixed chimerism to promote immunological tolerance in SOT recipients. A total of 10 participants will be recruited, either prior to their scheduled SOT or having already undergone SOT (in case of renal transplant recipients with a living donor), depending on enrollment feasibility.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francisco Hernández Oliveros
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francisco Hernández Oliveros, Hospital Universitario La Paz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997471
- Sponsor's protocol ID
- DUALGRAFT
- Acronym
- DUALGRAFT
- Status last verified
- May 2025
- First submitted
- 14 May 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perez-Martinez A, Aguirre-Portoles C, Mestre-Duran C, Arreola NM, Pascual-Miguel B, Stringa P, Lopez Oliva MO, Papa-Gobbi R, Gonzalez-Sacristan R, Gasior M, Marcos A, de Paz R, Alonso JM, Al-Akioui-Sanz K, Pertinez L, Ferreras C, Tobes R, Pareja E, Balas A, Vicario JL, Estebanez B, Munoz Fernandez de Legaria M, Ramos-Boluda E, Sanz S, Jimenez C, Camps O, Andres AM, Hernandez-Oliveros F. Naive T cell-depleted hematopoietic stem cell transplantation to minimize immunosuppression after solid organ transplantation: case report. Commun Med (Lond). 2026 Sep 21;6(1):489. doi: 10.1038/s43856-026-01906-x.
PubMed 42768153
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Center, Open-Label Trial to Assess the Safety and Tolerability of Delayed Infusion of a Naïve T Cell Depleted Hematopoietic Graft and Memory T-lymphocytes in Recipients of Solid Organ Transplantation
- ClinicalTrials.gov ID
- NCT06997471
- Acronym / sponsor ID
- DUALGRAFT / DUALGRAFT
- Conditions
- Solid Organ Transplant Complications, Solid Organ Transplant Recipients, Solid Organ Transplant Rejection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Francisco Hernández OliverosUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 30 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial is exploring a new way to help patients who receive a solid organ transplant-such as a kidney, lung, or intestine-live longer and healthier lives with fewer side effects from medication. Today, most transplant recipients must take strong immune-suppressing drugs every day to prevent their bodies from rejecting the new organ. While these drugs are essential, they can lead to serious complications over time, such as infections, and even damage to the transplanted organ itself.
The goal of this study is to test a promising strategy that may help the body naturally accept the transplanted organ, reducing or potentially eliminating the need for long-term immunosuppressive drugs. This approach involves a technique called mixed hematopoietic chimerism, which means that the patient's body receives a mix of immune cells from both themselves and the organ donor. When successful, this blend of immune systems can lead to immune tolerance, allowing the transplanted organ to function without being attacked by the patient's immune system.
This is a Phase I, single-center, open-label clinical trial, which means it is an early-stage study focused primarily on evaluating safety. The trial will enroll 10 patients who are either scheduled to receive a solid organ transplant (SOT) or have recently undergone one, depending on the type of organ and donor availability.
After a transplant, each patient must go through a stabilization period, allowing time for any immediate post-surgical complications to improve. Once stabilized, the patient will receive a specially prepared infusion of blood-forming (hematopoietic) stem cells from their organ donor. This process is known as hematopoietic stem cell transplantation (HSCT).
Before this infusion, patients will undergo low-dose preconditioning using total lymphoid irradiation (TLI) and thymic irradiation. These treatments prepare the body to accept the donor's cells without causing major immune damage, and they aim to lower the risk of complications like graft-versus-host disease (GVHD)-a serious condition where donor immune cells attack the patient's tissues.
The infused cell product is carefully designed:
- It includes CD34+ blood stem cells, which help rebuild the patient's immune and blood systems.
- It removes "naïve" T cells (CD45RA+), which are known to cause GVHD.
- It includes "memory" T cells (CD45RO+), which support immune recovery and protection against infections.
In some cases, natural killer cells CD56+ may also be included to help protect against viruses and support tolerance-especially when the donor is haploidentical.
The way the cells are collected depends on whether the donor is living or deceased. For living donors, peripheral blood stem cells are collected. For deceased donors, the bone marrow is used.
This trial is based on encouraging results from earlier studies and aims to show that this strategy is safe and feasible. If successful, the benefits could be wide-ranging:
- Less dependence on lifelong immunosuppressive medications
- Lower risk of chronic rejection of the transplanted organ
- Fewer life-threatening infections
- Improved quality of life, especially for children and young adults
- Increased availability of transplantable organs by improving outcomes and reducing re-transplantation needs
- Lower healthcare costs due to fewer complications, hospitalizations, and medications
The study will also track how well the patient's body accepts the transplanted organ over time and whether true immune tolerance is achieved. This will be monitored by looking at immune markers in the blood and through regular clinical follow-ups.
This approach could be especially helpful for pediatric patients, who face unique challenges, such as difficulty adhering to lifelong medication plans and a higher risk of needing multiple transplants. It may also help adult patients at high risk of rejection, or those who have already had complications with previous transplants.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single-center, open-label clinical trial. Its primary goal is to evaluate the safety of inducing hematopoietic mixed chimerism to promote immunological tolerance in SOT recipients. A total of 10 participants will be recruited, either prior to their scheduled SOT or having already undergone SOT (in case of renal transplant recipients with a living donor), depending on enrollment feasibility.
| Arm | Type | Receives |
|---|---|---|
| HSCT using a graft enriched in CD34+ hematopoietic progenitor cells | Experimental | Biological: Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytesThe study intervention involves a HSCT using a graft enriched in CD34+ hematopoietic progenitor cells. This graft will be specifically engineered through depletion of naïve T-lymphocytes (CD45RA+) and patients will be supplemented with memory lymphocytes to support immune reconstitution and promote tolerance. The source of the hematopoietic stem cells (HSCs) will vary depending on whether the donor is a living related donor (HLA-identical or haploidentical) or a deceased donor. Graft Composition and Cell Doses * CD34+ cells: < 1 x 107/kg will be intravenously infused as the primary source of hematopoietic progenitors. * Memory T-lymphocytes (CD45RO+): < 3 x 107/kg will be administered. Naïve T-lymphocytes (CD45RA+) remaining in the memory fraction will always be <1 x 104/kg, to minimize the risk of GVHD while supporting immune surveillance. * Only in haploidentical participants: NK cells (CD56+): < 5 x 107/kg to promote graft tolerance and target residual malignant cells. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytesInfusion 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 | Biological | HSCT using a graft enriched in CD34+ hematopoietic progenitor cells |
Primary outcome
Incidence of adverse events related to the investigational intervention.
Time frame: From enrollment to end of follow-up at 2 years after cell therapy administration
Safety and tolerability will be evaluated based on the incidence, nature and and severity of adverse events during study period. (clinical and laboratory).
14 secondary outcomes
Feasibility of cell collection, processing and administration.
Time frame: From enrollment to 3 months after solid organ transplantation
Mixed hematopoietic chimerism measurement.
Time frame: From therapy administration to 30 days and 100 days after investigational therapy administration
Donor-Specific T Cell Clone Depletion
Time frame: One year post haematopoietic stem cell therapy and thereafter.
Organ Rejection Rate
Time frame: From investigational therapy administration to 1 year after
Graft Survival and Failure Rates
Time frame: From enrollment to end of follow-up at 2 years after cell therapy administration
occurence of GVHD in patients receiving delayed infusion of the investigational celular therapy after solid organ transplantation.
Time frame: From enrollment to end of follow-up at 2 years after cell therapy administration
Occurrence of infections in patients receiving delayed infusion of the investigational celular therapy after solid organ transplantation.
Time frame: From enrollment to end of follow-up at 2 years after cell therapy administration
Immune reconstitution in patients receiving delayed infusion of the investigational celular therapy after solid organ transplantation
Time frame: Day 100 post haematopoietic stem cell therapy.
Immune reconstitution in patients receiving investigational cell therapy
Time frame: From enrollment to end of follow-up at 2 years after cell therapy administration
Development of immune tolerance in transplant recipients
Time frame: One-year post haematopoietic stem cell therapy and thereafter.
Recipient's laboratory hyporesponsiveness towards the graft
Time frame: One-year post haematopoietic stem cell therapy and thereafter.
Recipient's competence against third party donors
Time frame: One-year post haematopoietic stem cell therapy and thereafter.
Recipient's competence against virus
Time frame: One-year post haematopoietic stem cell therapy and thereafter.
Mortality after investigational therapy adminitration.
Time frame: From enrollment to one year after investigational therapy administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Derived from this study: PubMed 42768153Perez-Martinez A, Aguirre-Portoles C, Mestre-Duran C, Arreola NM, Pascual-Miguel B, Stringa P, Lopez Oliva MO, Papa-Gobbi R, Gonzalez-Sacristan R, Gasior M, Marcos A, de Paz R, Alonso JM, Al-Akioui-Sanz K, Pertinez L, Ferreras C, Tobes R, Pareja E, Balas A, Vicario JL, Estebanez B, Munoz Fernandez de Legaria M, Ramos-Boluda E, Sanz S, Jimenez C, Camps O, Andres AM, Hernandez-Oliveros F. Naive T cell-depleted hematopoietic stem cell transplantation to minimize immunosuppression after solid organ transplantation: case report. Commun Med (Lond). 2026 Sep 21;6(1):489. doi: 10.1038/s43856-026-01906-x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Investigational cellular therapy consisting on a HSCT using a graft enriched in CD34+, depleted of naïve T-lymphocytes and supplemented with memory lymphocytes in people with Solid Organ Transplant Complications and Solid Organ Transplant Recipients, run by Francisco Hernández Oliveros at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francisco María Hernández Oliveros, MD, PhD (+34 91 207 17 40, fhernandezo@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events related to the investigational intervention. (time frame: From enrollment to end of follow-up at 2 years after cell therapy administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06997471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.