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)

Recruiting now · Phase 2

Conditions studied: Acute Lymphocytic Leukemia (ALL)

In brief

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.

Key facts

Study ID

NCT07053059

Run by

M.D. Anderson Cancer Center

People needed

30

Starts

2025-08-26

Expected to finish

2030-05-31

Last updated by the study team

2026-05-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Ph-negative B-cell ALL:
• 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)
• TP53 mutation (variant allele fraction >2%)
• Persistent MRD by flow cytometry and/or NGS
• Ph-positive B-cell ALL:
• IKZF1plus genotype (IKZF1 deletion coexisting with PAX5 or CDKN2A/2B, or PAR1 region deletions) or other high-risk features such as VPRB1 deletion, etc.
• High WBC (>30 x 109/L) at initial presentation
• 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 V. Patients with controlled CNS and/or other extramedullary leukemia will be eligible.

You may not qualify if…

• 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

Where it is running

• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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