Using CD45RA Depleted Stem Cells to Prevent Infections After Transplant

Phase 1/2 Study: CD45RA Depleted Peripheral Stem Cell Addback to Prevent Viral and Fungal Infections Following Alternative Donor TCRab/CD19 Depleted Hematopoietic Stem Cell Transplant

This study is testing whether using special stem cells can help patients with high-risk leukemia recover their immune system faster and prevent infections after a stem cell transplant.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 1 Month to 25 Years
• Sex: All
• Sponsor: Children's Hospital of Philadelphia (other)
• Drugs / interventions: alemtuzumab, Immunotherapy
• Locations: 1 site (Philadelphia, Pennsylvania)
• Trial ID: NCT06839456 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of CD45RA depleted stem cells to enhance immune recovery and reduce the risk of infections following hematopoietic stem cell transplantation (HSCT) in patients with high-risk leukemia and other conditions. The study aims to determine the maximum tolerated dose of CD45RO memory T lymphocytes added back to the transplant process, which may help accelerate immune reconstitution. It includes both phase 1 and phase 2 components, focusing on patients receiving cells from mismatched or haploidentical related donors. The trial builds on previous research and expands eligibility to include a broader range of transplant indications.

Who should consider this trial

Good fit: Ideal candidates are patients aged 25 years or younger with hematologic malignancies or other conditions eligible for allogeneic HSCT.

Not a fit: Patients with performance scores below 60 or those with available 10/10 HLA matched sibling donors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of life-threatening infections in patients undergoing HSCT.

How similar studies have performed: Previous studies have shown promise with similar approaches, but this specific method is being tested in a novel context.

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.

Where this trial is running

Philadelphia, Pennsylvania

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Timothy Olson, MD, PhD — Children's Hospital of Philadelphia
• Study coordinator: Megan Atkinson

Conditions: Leukemia, High Risk Acute Lymphoblastic Leukemia, High Risk Acute Myeloid Leukemia, Relapse Leukemia, MDS, Relapsed Non-Hodgkin Lymphoma, Acquired Aplastic Anemia, Inherited BMF Syndrome