Selective cell removal may tame stem cell Transplant's dangerous side effect
NCT ID NCT07660783
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether removing a specific type of immune cell (naive T cells) from a donor's stem cell graft can prevent graft-versus-host disease (GVHD), a serious complication where donor cells attack the recipient's body. The trial enrolls people with non-malignant blood disorders such as bone marrow failure, sickle cell disease, or immune deficiencies who need a stem cell transplant. Participants receive chemotherapy and low-dose radiation before the specially processed donor stem cells are infused.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD34-enriched, CD45RA-depleted donor stem cells
- What this could lead to
- If successful, this approach could reduce severe graft-versus-host disease after stem cell transplant for non-malignant blood disorders, improving safety and quality of life.
- What could go wrong
- This is a small, early-phase trial. The special graft may not prevent GVHD as hoped, and risks like infection or graft failure remain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Sep 2026
An estimate. Start dates often move.
- Expected to finish
-
Sep 2035
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
6 months to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * Patient with suitable HCT donor (see inclusion criteria below) * Recipient informed consent/assent (13 years and older), and/or legal guardian permission must be obtained Exclusion Criteria: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Autoimmune cytopenia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
2 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
-
Seattle Children's Hospital
Seattle, Washington, 98105, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Gene editing offers hope for a One-Time sickle cell cure
- Can a One-Time gene infusion free patients from transfusions?
- Second chance: milder prep for stem cell transplants may help when first fails
- Military study probes Toxins' role in lymphoma
- Blood test could predict bleeding risk in cancer patients
- Could a common vitamin a drug tame a deadly immune storm?