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)

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join 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 cannot join 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

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Obecabtagene autoleucel (Drug): given by Infusion

Na · Single Group · masking: None

Main goals

• Safety and Adverse Events (AEs) (Through study completion; an average of 1 year)

Planned enrollment: 30 (estimated).

• The University of Texas M. D. Anderson Cancer Center, Houston, Texas

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07053059

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 11, 2026. Public record; not medical advice.