New immune cell boost may shield kids from Post-Transplant infections
NCT ID NCT06839456
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding memory immune cells (CD45RO) to a stem cell transplant can help children fight off dangerous viral and fungal infections after the procedure. The transplant uses donor stem cells that have been stripped of certain cells to prevent graft-versus-host disease, but this can leave the immune system weak. By adding back memory cells, researchers hope to speed up immune recovery without increasing the risk of graft-versus-host disease. The study involves 100 children and young adults up to age 25 with blood cancers, immune disorders, or bone marrow failure.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Mar 2032
An estimate. End dates often move.
- Lead sponsor
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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
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1 month to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Disease for which allogeneic HSCT may be curative. 2. Remission status of hematologic malignancies and additional disease-specific eligibility determinations will be according to standards of practice within the CHOP Cellular Immunotherapy and Transplant Program (CTTS). 3. Patients must be 25 years of age and less 4. Evaluation for organ and infectious status as per our CTTS standard operating procedure. 5. Signed consent by parent/guardian or able to give consent if 18 years of age and older. 6. Participants of childbearing potential must have a negative pregnancy test as per institutional SOP. Exclusion Criteria: 1. Patients who have performance score less than 60. 2. No suitable donor available for mobilized peripheral stem cells. 3. Patients with Hodgkin lymphoma or non-Burkitt, non-lymphoblastic lymphoma. 4. Planned receipt of alemtuzumab during conditioning. 5. Patients with an available 10/10 HLA matched sibling donor. 6. Patients who do not meet institutional disease, organ or infectious criteria. Donor selection and eligibility: 1. Unrelated donor meets National Marrow Donor Program criteria for donation. 2. Related donor (at least haploidentical) willing and able to donate mobilized peripheral stem cells. 3. HLA testing/matching * HLA testing to be done by molecular methods for A, B, C, DRB1, DQB1 * Related donor: Must be ≥ 5/10 match * Unrelated donor: 10/10 or 9/10 match * KIR typing for haploidentical donor for hematologic malignancies * Donor specific HLA antibodies (DSA) should be assessed for all subjects receiving an HLA mismatched graft (≤ 9/10). 4. Donor must be willing to undergo granulocyte colony stimulating factor (GCSF) mobilization and peripheral blood stem cell collection 5. Donors must be willing to sign consent to participate in this study.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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Other studies related to the condition(s) this trial covers.
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