About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Obecabtagene autoleucel
Treatment groups
Sponsors and collaborators
M.D. Anderson Cancer Center
Lead sponsor
Autolus, Ltd
Collaborator