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Phase 1/2 Study for Preventing Infections After Stem Cell Transplant

This study is for children and young adults (ages 1 month to 25 years) with certain blood cancers like leukemia or myelodysplastic syndrome (MDS) who are undergoing a stem cell transplant. After a type of transplant that helps prevent graft-versus-host disease (GVHD – a complication where donor cells attack the patient's body), there's a risk of serious infections. This study is testing if adding back specific donor immune cells, called CD45RO+ T cells, can help the immune system recover faster and reduce the risk of these infections. The study will look at how safe different doses of these cells are and how well they prevent GVHD. The study plans to enroll 100 participants.

Study design
This is a Phase 1/2 interventional study. It will involve different dose levels of the CD45RA depleted addback, with 100 participants planned.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for acute GVHD for up to 100 days post-transplantation and for chronic GVHD for up to 2 years post-transplantation.

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NCT06839456

Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT

Recruiting
PHASE1Ages 1–25InterventionalTreatment
Children's Hospital of Philadelphia
~100 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Phase 1 Dose Level 1Phase 1 Dose Level 2Phase 1 Dose Level 3Phase 2 Maximum Tolerated Dose determined in Phase 1Phase 2 Established Dose from prior study, NCT03810196

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Evaluate number of patients with acute graft vs host disease (aGVHD)
Measured over Up to 100 days post-transplantation
+1 more outcome measured

Conditions

Leukemia
High Risk Acute Lymphoblastic Leukemia
High Risk Acute Myeloid Leukemia
Relapse Leukemia
MDS (Myelodysplastic Syndrome)
Relapsed Non-Hodgkin Lymphoma
Acquired Aplastic Anemia
Inherited BMF Syndrome
Immunodeficiency
Primary Immune Regulatory Disorder
Hemoglobinopathies
Bone Marrow Failure
Inborn Errors of Metabolism
HLH

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Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Timothy Olson, MD, PhD · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Megan Atkinson
[email protected]
215-590-2820
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Eligibility criteria

Exclusion

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.

What this trial measures

  • Evaluate number of patients with acute graft vs host disease (aGVHD)Up to 100 days post-transplantation

    Safety evaluation assessment by cumulative incidence of acute graft vs host disease (reaction of donor immune cells against host tissues) to determine percentage of patients that develop grade 3-4 aGVHD.

  • Evaluate number of patients with chronic graft vs host disease (cGVHD)Up to 2 years post-transplantation

    Safety evaluation assessment by cumulative incidence and severity of chronic GVHD (graft vs host disease that occurs more than 100 days after transplant) to determine percentage of patients that develop cGVHD.