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Naive T Cell Depleted Grafts for GVHD Prevention

This study is looking at a special type of stem cell transplant to help prevent graft-versus-host disease (GVHD) in people with certain non-cancerous conditions. GVHD is a complication where the donor's immune cells attack the patient's body. You would receive a transplant using donor peripheral blood stem cells that have been specially prepared to remove certain immune cells (CD34+ enriched and CD45RA- depleted). Before the transplant, you would receive chemotherapy (cyclophosphamide, fludarabine, thiotepa) and total-body irradiation (TBI) to prepare your body. After the transplant, you would also receive medications like tacrolimus and mycophenolate mofetil (MMF) to further prevent GVHD. This study aims to see how many patients are alive and free of GVHD one year after the transplant. You may be eligible if you are between 6 months and 50 years old and have conditions like bone marrow failure, hemoglobinopathies, or immune deficiencies.

Study design
This is an interventional study with a planned enrollment of 40 participants. The phase of the study is not specified.
What's involved
You would receive several medications intravenously (IV) and undergo total-body irradiation. You would also have bone marrow aspirations/biopsies and blood sample collections throughout the trial.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will have follow-up visits at specific times for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07660783

Naive T Cell Deplete Grafts for GVHD Prevention in Non-Malignant Diseases

Not Yet Recruiting
PHASE2Ages 6–50InterventionalTreatment
Fred Hutchinson Cancer Center
~40 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:ALLOGENEIC CD34+ ENRICHED AND CD45RA- DEPLETED PBSCs

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
GVHD-free Survival
Measured over 1 year post-transplant

Conditions

Bone Marrow Failure
Hemoglobinopathies
Primary Immune Deficiency (PID)
Autoimmune Cytopenia
Immune Dysregulation
Hemophagocytic Lymphohistiocytosis (HLH)
Non Malignant Disorders

Explore related trials

Autoimmune CytopeniaHemoglobinopathyHemophagocytic LymphohistiocytosisImmune dysregulationInborn Error of ImmunityNon-Malignant DisordersPancytopenia

NCT07660783

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Fred Hutchinson Cancer Center

    Seattle, Washingtonno site contact published

  • Seattle Children's Hospital

    Seattle, Washingtonno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Madhavi Lakkaraja, MD, MPH · PRINCIPAL_INVESTIGATOR · Fred Hutch Cancer Center

Who to contact

Madhavi Lakkaraja, MD, MPH
[email protected]
206-667-7166
Email the study team

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Eligibility criteria

Inclusion

Considered appropriate candidate for allogeneic HCT following low dose (4Gy) TBI containing-conditioning and have one of the following diagnoses: A) BMF B)Hemoglobinopathies C)PID D) Autoimmune cytopenias E) Immune dysregulation F) HLH G) Other NMD treatable by HCT and NMD that is not clearly defined (a patient with a NMD for whom genetic testing has been done and a genetic mutation responsible for their NMD phenotype has not been identified) are eligible for the study following discussion with and approval by the protocol PI
Patients aged 6 months- 5 years old (inclusive) at the time of informed consent
Recipient informed consent/assent (13 years and older), and/or legal guardian permission must be obtained

Exclusion

Patient with aplastic anemia
Patients with severe combined immunodeficiency (SCID)
Fanconi anemia
Dyskeratosis congenita
Patient weight \> 100 kg
Patients who are positive for HIV-1, HIV-2
Patients with current neoplastic disorders
Patients with uncontrolled infections for whom HCT is considered contraindicated by the consulting infectious disease physician.
Patients with organ dysfunction including A) Renal insufficiency B) Impaired cardiac function C)Impaired pulmonary function D) Liver dysfunction
Patients who are pregnant or breast-feeding
Patients on other experimental protocols for prevention of GVHD
Patients of childbearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during and for 12 months post-HCT
Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI
Patients with a known hypersensitivity to tacrolimus or MMF

What this trial measures

  • GVHD-free Survival1 year post-transplant

    Free of grade III-IV acute and NIH chronic (moderate-severe) GVHD requiring systemic immunosuppression