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)

Launched by M.D. ANDERSON CANCER CENTER · Jun 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called obecabtagene autoleucel (obe-cel) to see if it can help patients with a type of blood cancer called high-risk B-cell acute lymphocytic leukemia (ALL) after their initial treatment. This treatment is given as "consolidation therapy," which means it’s used to strengthen the results of the first phase of treatment and help keep the cancer under control.

The study is for adults 18 years and older who have just been diagnosed with high-risk B-cell ALL and are currently in their first remission (meaning the cancer is under control after initial treatment). To join, patients must have certain high-risk features in their leukemia cells or test results, have good overall health, and show specific markers on their cancer cells. People who are pregnant, have certain infections, or cannot give consent will not be eligible. Participants will receive the study treatment and be closely monitored for how well it works and for any side effects. This trial is not yet open for new patients to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• I. Patients of age .18 years with high-risk B-cell ALL in first remission and \<5% BM blasts with at least one high-risk feature defined as:
• • a. Ph-negative B-cell ALL: i. KMT2A rearranged ALL ii. Complex cytogenetics as per NCCN 2022 iii. Low-hypodiploidy/tetraploidy iv. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions) v. TP53 mutation (variant allele fraction \>2%) vi. Persistent MRD by flow cytometry and/or NGS b. Ph-positive B-cell ALL: i. IKZF1plus genotype (IKZF1 deletion coexisting with PAX5 or CDKN2A/2B, or PAR1 region deletions) or other high-risk features such as VPRB1 deletion, etc. ii. High WBC (\>30 x 109/L) at initial presentation iii. Persistent MRD by flow cytometry and/or NGS and/or PCR II. Performance status of 0, 1, or 2 III. Adequate organ function with creatinine less than or equal to 1.6 mg/dl, bilirubin less than or equal to 3.5 mg and ALT and AST less than or equal to 5 times institutional upper limit of normal IV. Patients should be CD19 expression positive (\>1%) before enrollment VII. Patients with controlled CNS and/or other extramedullary leukemia will be eligible.
• Exclusion Criteria:
• • 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