Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

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

30 Participants
are divided into 1 treatment group

Sponsors and collaborators