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)
M.D. Anderson Cancer Center
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.
Description
Primary Objectives To assess the Efficacy of Obecabtagene autoleucel \[anti-CD19 autologous derived chimeric antigen receptor T-cell (CAR-T)\] in terms of EFS in patients with newly diagnosed high-risk B-cell ALL (defined by baseline high-risk genomics or persistent MRD) post cytoreductive chemoimmunotherapy: 18-month EFS Secondary Objectives: 1. 24-month overall survival (OS) 2. For Ph-negative B-cell ALL: Rate of persistent MRD negativity by flow cytometry and NGS at 18 months 3. For Ph-positive B-cell ALL: Rate of persistent MRD negativity by flow cytometry, NGS and BCR::ABL1 qPCR (CMR) a…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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, o…
Interventions
- DrugObecabtagene autoleucel
given by Infusion
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas