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Study of Brexucabtagene Autoleucel for B-cell Acute Lymphocytic Leukemia

This study is looking at a treatment called brexucabtagene autoleucel (a type of CAR T-cell therapy, which uses your own specially modified immune cells to fight cancer) for people with B-cell acute lymphocytic leukemia (ALL) that has come back or not responded to previous treatment (relapsed/refractory), or for those newly diagnosed with high-risk ALL. Before receiving brexucabtagene autoleucel, participants will be treated with a combination of other medicines: blinatumomab, inotuzumab ozogamicin, and either hyper-CVAD (for those under 60) or mini-hyper-CVD (for those 60 and older). The main goals are to understand how safe brexucabtagene autoleucel is and if it helps control the disease after these initial treatments. This study is currently recruiting 40 participants.

Study design
This is an interventional study with a planned enrollment of 40 participants. The phase of the study is not specified, and the status is unclear.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

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NCT06287229

Phase Ib/II Study Assessing the Clinical Activity and Safety of Brexucabtagene Autoleucel as a Consolidation in Patients With Relapsed/Refractory (R/R) and Newly Diagnosed B-cell Acute Lymphocytic Leukemia (ALL) Post Cytoreduction With Mini-HCVD-inotuzumab-blinatumomab/HCVAD-inotuzumab-blinatumomab

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~40 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:BlinatumomabInotuzumab OzogamicinHyper-CVADMini-hyper-CVD

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Relapsed/Refractory
B-cell Acute Lymphocytic Leukemia

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B Acute Lymphoblastic LeukemiaCD19 GeneCytokine Receptor-Like Factor 2KMT2A Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Elias Jabbour, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Elias Jabbour, MD
[email protected]
(713) 792-4764
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants of age ≥18 years with documented relapsed or refractory B-cell ALL
In the newly diagnosed cohort: Participants of age ≥18 years with high-risk newly diagnosed B-cell ALL defined as:
Performance status of 0, 1, or 2
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
Participants should be CD19 expression positive (\>50%) before enrollment
Participants with chronic viral infections like Hepatitis B-virus, Hepatitis C virus or Human Immunodeficiency virus I/II will be eligible if they are on therapy and infections are under control.

Exclusion

Philadelphia positive B-cell ALL
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
Prior exposure to brexu-cel or other anti-CD-19 CAR T cell therapy
Active and uncontrolled disease/infection as judged by the treating physician
Unable or unwilling to sign the consent form
No other investigational therapy within the past 14 days

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0