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

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Feb 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new approach to help prevent serious infections in patients with certain types of blood cancers, such as leukemia and lymphoma, after they receive a stem cell transplant from a donor. The trial is testing whether adding back a specific type of immune cell, called memory T lymphocytes, can help patients recover their immune system more quickly after the transplant. This is important because patients often struggle with infections due to a weakened immune system after the transplant.

To be eligible for this trial, participants must be 25 years old or younger and have a disease that could be treated with a stem cell transplant. They also need to be in remission and have a suitable donor who can provide stem cells. The study is currently recruiting participants, and those who join can expect close monitoring and support throughout the process. This trial aims to improve safety and outcomes for young patients undergoing this potentially life-saving procedure.

Gender

ALL

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.