ALL-1052: Brexucabtagene Autoleucel (Brexu-Cel) as Consolidation Treatment in Adults With B-Cell Acute Lymphoblastic Leukemia (B-ALL): Efficacy and Toxicity in a Real-World Setting

Niranjan Khaire; Elias Jabbour; Nicholas Short; Shilpa Paul PharmD; Alexandra Lovell; Jayastu Senapati; Fadi Haddad; Tapan Kadia; Naveen Pemmaraju; Naval Daver; Rabiul Islam; Sa Wang; Beenu Thakral; Partow Kebriaei; Bouthaina Dabaja; Elizabeth Shpall; Sattva Neelapu; William Wierda; Farhad Ravandi; Hagop Kantarjian; Nitin Jain

doi:10.1016/S2152-2650(25)01572-1

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ALL-1052: Brexucabtagene Autoleucel (Brexu-Cel) as Consolidation Treatment in Adults With B-Cell Acute Lymphoblastic Leukemia (B-ALL): Efficacy and Toxicity in a Real-World Setting

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ALL-1052: Brexucabtagene Autoleucel (Brexu-Cel) as Consolidation Treatment in Adults With B-Cell Acute Lymphoblastic Leukemia (B-ALL): Efficacy and Toxicity in a Real-World Setting

Niranjan Khaire, Elias Jabbour, Nicholas Short, Shilpa Paul PharmD, Alexandra Lovell, Jayastu Senapati, Fadi Haddad, Tapan Kadia, Naveen Pemmaraju, Naval Daver, …

Clinical lymphoma, myeloma and leukemia, Vol.25(Suppl 1), pp.S374-S375

09/2025

DOI: 10.1016/S2152-2650(25)01572-1

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Abstract

Brexu-cel is a CD19 CAR-T therapy approved for adult patients with R/R B-ALL. The ZUMA-3 trial required patients to have >5% marrow blasts. Evaluate real-world toxicity/efficacy of brexu-cel in adults with marrow blasts <5%. Retrospective analysis of adults with B-ALL receiving standard-ofcare brexu-cel (clinical trials excluded) at MDACC. Inclusion criteria: marrow blasts <5%, no active EMD. Serial peripheral blood CAR-T levels were monitored using anti-FMC63-based flow cytometry. Only patients with available NGS MRD (ClonoSEQ® assay) and CAR-T data were included. Fifty-two patients (median age, 36.5 years [range, 20–84]) received brexu-cel (2/2022–2/2025). Eighteen (35%) had Ph+ ALL; 10 (19%) had Ph-like ALL. The median number of prior therapies (including blinatumomab [98%], inotuzumab [77%], allo-SCT [15%]) was 2 (range, 1–8); 10 patients received CAR-T in CR1. Pre-infusion, 38/52 were MRD-negative; 14/52 were MRD-positive (2–3,283 cells/million). Peak CAR-T expansion was 11.5 cells/μL (range, 1–2,222) at median 8 days post infusion. A 15-cells/μL peak expansion threshold was identified as the optimal RFS predictor. Twenty-five (48%) patients had peak expansion ≥15 cells/μL, 2 of whom relapsed; of 27 (52%) with expansion <15 cells/μL, 12 relapsed. Among pre-CAR-T NGSMRD-positive patients (n = 14), median peak expansion was 36.5 cells/μL (range, 1–573); 8/14 (57%) had peak ≥15 cells/μL. Among pre-CAR-T NGS-MRD-negative patients (n = 38), median peak expansion was 11 cells/μL (range, 1–2,222); 17/38 (44%) had peak ≥15 cells/μL. At 13.0-month median follow-up, 12-month RFS was 65% for the whole cohort (79% in expansion ≥15 cells/μL; 53% in expansion <15 cells/μL). Twelve-month OS was 91% for all. Five patients underwent allo-SCT after CAR-T infusion at median 3.5 months (range, 1.6–4.2) at physician discretion. G3 CRS occurred in one patient (2%), and G3–4 ICANS in five (10%) (G3, n = 3; G4, n = 2). Twenty-two (42%) and 13 (25%) received tocilizumab and dexamethasone, respectively. The 5 patients with G3-4 CRS/ICANS had peak expansion of 102, 124, 573, 1,270, and 2222 cells/μL. Brexu-cel as a consolidation strategy demonstrates CART expansion even in patients with no morphologic disease. A ≥15-cells/μL expansion threshold predicts durable RFS and demonstrates low rates of G3–4 CRS/ICANS.

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Title: Subtitle: ALL-1052: Brexucabtagene Autoleucel (Brexu-Cel) as Consolidation Treatment in Adults With B-Cell Acute Lymphoblastic Leukemia (B-ALL): Efficacy and Toxicity in a Real-World Setting
Creators: Niranjan Khaire - The University of Texas MD Anderson Cancer Center
Elias Jabbour - The University of Texas MD Anderson Cancer Center
Nicholas Short - The University of Texas MD Anderson Cancer Center
Shilpa Paul PharmD - The University of Texas MD Anderson Cancer Center
Alexandra Lovell - The University of Texas MD Anderson Cancer Center
Jayastu Senapati - The University of Texas MD Anderson Cancer Center
Fadi Haddad - The University of Texas MD Anderson Cancer Center
Tapan Kadia - The University of Texas MD Anderson Cancer Center
Naveen Pemmaraju - The University of Texas MD Anderson Cancer Center
Naval Daver - The University of Texas MD Anderson Cancer Center
Rabiul Islam - The University of Texas MD Anderson Cancer Center
Sa Wang - The University of Texas MD Anderson Cancer Center
Beenu Thakral - The University of Texas MD Anderson Cancer Center
Partow Kebriaei - The University of Texas MD Anderson Cancer Center
Bouthaina Dabaja - The University of Texas MD Anderson Cancer Center
Elizabeth Shpall - The University of Texas MD Anderson Cancer Center
Sattva Neelapu - The University of Texas MD Anderson Cancer Center
William Wierda - The University of Texas MD Anderson Cancer Center
Farhad Ravandi - The University of Texas MD Anderson Cancer Center
Hagop Kantarjian - The University of Texas MD Anderson Cancer Center
Nitin Jain - The University of Texas MD Anderson Cancer Center
Resource Type: Abstract
Publication Details: Clinical lymphoma, myeloma and leukemia, Vol.25(Suppl 1), pp.S374-S375
DOI: 10.1016/S2152-2650(25)01572-1
ISSN: 2152-2650
Publisher: Elsevier Inc
Language: English
Date published: 09/2025
Academic Unit: Internal Medicine
Record Identifier: 9985240981002771

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