Phase 1 Study of Autologous Anti-CD45 CAR T Cells in Combination With CD45 Base Edited HSPCs in Patients With Relapsed or Refractory Hematologic Malignancies
University of Pennsylvania
Summary
This is a phase 1, open-label, dose-finding study to assess the safety, feasibility, pharmacokinetics and preliminary efficacy of autologous base edited anti-CD45 CAR T cells (referred to as "CART-45 cells") following an autologous transplant of CD45 base edited hematopoietic stem and progenitor cells (referred to as "CD45BE-HSPC") in patients with relapsed or refractory hematologic malignancies.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1\. Signed informed consent form 2. Male or females age ≥ 18 years 3. Disease-Specific Criteria a. B-cell Non-Hodgkin Lymphoma (B-cell NHL)- including the following sub-types: i. Patients with any of the following large B-cell lymphoma diagnoses who meet the prior treatment criteria outlined below: Diffuse Large B-cell Lymphoma not otherwise specified (DLBCL NOS); Primary Cutaneous DLBCL; Primary Mediastinal (thymic) Large B-cell Lymphoma; ALK+ Anaplastic Large B-cell Lymphoma; High-Grade B-cell Lymphoma with MYC and BCL2 and/or BCL6 rearrangements (i.e., "Double or Trip…
Interventions
- BiologicalCART-45 cells
Autologous base edited anti-CD45 CAR T cells
- BiologicalCD45BE-HSPC
CD45 base edited hematopoietic stem and progenitor cells
Location
- University of PennsylvaniaPhiladelphia, Pennsylvania