NCT06839456 Phase 1/2: CD45RA Depleted Stem Cell Addback to Prevent Viral or Fungal Infections Post TCRab/CD19 Depleted HSCT
| NCT ID | NCT06839456 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-21 |
| Primary Completion | 2031-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2025-03-21 with a primary completion date of 2031-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The major morbidities of allogeneic hematopoietic stem cell transplant (HSCT) using donors that are not human leukocyte antigen (HLA) matched siblings are graft vs host disease (GVHD) and life- threatening infections. T cell receptor alpha beta (TCRαβ) T lymphocyte depletion and CD19+ B lymphocyte depletion of alternative donor hematopoietic stem cell (HSC) grafts is effective in preventing GVHD, but immune reconstitution may be delayed, increasing the risk of infections. The central hypothesis of this study is that an addback of CD45RO memory T lymphocytes, derived from a fraction of the original donor peripheral stem cell product depleted of CD45RA naïve T lymphocytes, will accelerate immune reconstitution and help decrease the risk of infections in TCRab/CD19 depleted PSCT.
Eligibility Criteria
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.
Contact & Investigator
Timothy Olson, MD, PhD
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT06839456 clinical trial?
This trial is open to participants of all sexes, aged 1 Month or older, up to 25 Years, studying Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06839456 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06839456 currently recruiting?
Yes, NCT06839456 is actively recruiting participants. Contact the research team at cttsbmtintake@chop.edu for enrollment information.
Where is the NCT06839456 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06839456 clinical trial?
NCT06839456 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Timothy Olson, MD, PhD at Children's Hospital of Philadelphia. The trial plans to enroll 100 participants.
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