CD33 CAR T cells / Beijing Boren Hospital - LARVOL DELTA

The Safety and Efficacy of CD33 CAR-T Therapy for RR AML after HSCT (ASH 2024) - "The leukemia cells of all patients expressed CD33 before treatment and after excluding contraindications to CAR-T cell therapy, chemotherapy based on fludarabine was given as a pre-treatment regimen, then transfused hCD33 CAR-T cells collected from the donor or the patients with 6.2 × 104/kg~6.15 × 105/kg. Conclusions : As a salvage treatment for rr AML including those who relapse after allo-HSCT,our hCD33 CAR-T resulted in CR rate of 41.67% which already was better than other treatment such as chemotherapy,donor lymphocyte reinfusion (DLI)even other CAR-Ts; On the other hand, our experience , although we recommend patients to bridging secondary transplantation or donor stem cell reinfusion to support hematopoiesis after CD33 CAR-T, but actually CD33 CAR-T side effects can be controlled, and some patients can survive without bridging the secondary transplantation. So for rr AML patients even after allo-HSCT, CD33 CAR-T is still recommended."

Clinical • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Central Nervous System Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • Septic Shock • CD33

Phase I/II Study of Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=5 | Completed | Sponsor: Beijing Boren Hospital | Recruiting ➔ Completed | N=25 ➔ 5

CAR T-Cell Therapy • Enrollment change • Trial completion • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33

Phase I study of functionally enhanced CD33 CAR T cells in patients with relapsed or refractory acute myeloid leukemia. (ASCO 2024) - P1/2 | "We report the safety and efficacy of functionally enhanced CD33 CAR T cells. While some patients had CRi, there was also depletion of CD33-positive normal cells. Thus, further research is needed to address the issue of normal cell depletion."

CAR T-Cell Therapy • Clinical • P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Neutropenia • Oncology • Septic Shock • Thrombocytopenia • Transplantation • CD123 • CD33 • IL3RA

Phase I/II Study of Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2 | N=25 | Recruiting | Sponsor: Beijing Boren Hospital | Trial primary completion date: Sep 2022 ➔ Sep 2024

CAR T-Cell Therapy • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33

Phase I/II Study of Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2; N=25; Recruiting; Sponsor: Beijing Boren Hospital; Initiation date: Sep 2021 ➔ Apr 2021

CAR T-Cell Therapy • Clinical • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33

Phase I/II Study of Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1/2; N=25; Recruiting; Sponsor: Beijing Boren Hospital; Phase classification: P1 ➔ P1/2; Trial completion date: Apr 2024 ➔ Sep 2024; Initiation date: Apr 2021 ➔ Sep 2021; Trial primary completion date: Apr 2022 ➔ Sep 2022

CAR T-Cell Therapy • Clinical • Phase classification • Trial completion date • Trial initiation date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33

Open-Label, Nonramdominzed, Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Functionally Enhanced CD33 CAR T Cells in Subjects With Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1; N=20; Recruiting; Sponsor: Beijing Boren Hospital

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33