CD33CART / Center for International Blood and Marrow Transplant Research - LARVOL DELTA

CD33 CAR T-Cells (CD33CART) for Children and Young Adults with Relapsed/Refractory AML: Dose-Escalation Results from a Phase I/II Multicenter Trial (ASH 2023) - P1/2 | "All subjects received pre-CD33CART lymphodepleting chemotherapy (LD) with fludarabine (75-120 mg/m2) and cyclophosphamide (900-1000 mg/m2). CD33CART manufacturing is feasible in children and AYAs with r/r AML with acceptable toxicity experienced in treated subjects. CD33CART expansion was best in subjects treated at DL4 (1 x 107/kg) with MRD negative CRs and transient myeloid aplasia occurring in 2 of 5 (40%) subjects evaluable for response (Table). Based on early clinical efficacy at DL4, enrollment continues in the phase 2 portion."

CAR T-Cell Therapy • Clinical • P1/2 data • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Obesity • Palliative care • Pediatrics

17-CD33CART: Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=52 | Recruiting | Sponsor: Center for International Blood and Marrow Transplant Research | Active, not recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

17-CD33CART: Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=52 | Active, not recruiting | Sponsor: Center for International Blood and Marrow Transplant Research | Recruiting ➔ Active, not recruiting

Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=52 | Recruiting | Sponsor: Center for International Blood and Marrow Transplant Research | Active, not recruiting ➔ Recruiting | Trial primary completion date: Dec 2024 ➔ Dec 2029

Enrollment open • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Success of Centralized Manufacturing of CD33 CAR T-Cells (CD33CART) for Children and Young Adults with Relapsed/Refractory AML (TCT-ASTCT-CIBMTR 2024) - P1/2 | "Despite wide inter-patient heterogeneity of apheresis products, centralized manufacturing of CD33CART was feasible in children and young adults with r/r AML. Correlative analyses characterizing CD33CART products are ongoing."

CAR T-Cell Therapy • Clinical • Acute Myelogenous Leukemia • CD4 • CD8 • IL2

Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=52 | Active, not recruiting | Sponsor: Center for International Blood and Marrow Transplant Research | Recruiting ➔ Active, not recruiting | N=37 ➔ 52

Enrollment change • Enrollment closed • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology