The goal of this clinical research study is to learn if obecabtagene autoleucel (obe-cel) can help to control newly diagnosed, high-risk B-cell ALL when given as consolidation therapy. Consolidation therapy is given after the first phase of treatment.
KMT2A rearranged ALL
Complex cytogenetics as per NCCN 2022
Low-hypodiploidy/tetraploidy
Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)
Pregnant or lactating; women of child-bearing potential (WOCBP) must have negative pregnancy test. WOCBP defined as not post-menopausal for 12 months or no previous surgical sterilization.
Patients with history of Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV) infections, even if under control. (Patients with Hepatitis B core antibody positive alone will not be an exclusion factor if HBV DNA PCR is negative).
Active and uncontrolled disease/infection as judged by the treating physician
Unable or unwilling to sign the consent form
Single group
Obecabtagene autoleucel
Druggiven by Infusion
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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M.D. Anderson Cancer Center
Lead sponsor
Autolus, Ltd
Collaborator
