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)

Summary

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

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:

1. Ph-negative B-cell ALL:

   1. KMT2A rearranged ALL
   2. Complex cytogenetics as per NCCN 2022
   3. Low-hypodiploidy/tetraploidy
   4. Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)
   5. TP53 mutation (variant allele fraction \>2%)
   6. Persistent MRD by flow cytometry and/or NGS
2. Ph-positive B-cell ALL:

   1. IKZF1plus genotype (IKZF1 deletion coexisting with PAX5 or CDKN2A/2B, or PAR1 region deletions) or other high-risk features such as VPRB1 deletion, etc.
   2. High WBC (\>30 x 109/L) at initial presentation
   3. 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.

Exclusion Criteria:

1. 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.
2. 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).
3. Active and uncontrolled disease/infection as judged by the treating physician
4. Unable or unwilling to sign the consent form

Conditions2

Locations1 site

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