Actively Recruiting
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
Led by M.D. Anderson Cancer Center · Updated on 2026-04-24
40
Participants Needed
1
Research Sites
337 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To learn about the safety of giving the drug brexucabtagene autoleucel to participants with relapsed/refractory B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD. Also, to learn if giving brexucabtagene autoleucel to patients with relapsed/refractory or high-risk, newly diagnosed B-cell ALL after treatment with inotuzumab ozogamicin, blinatumomab, and either hyper-CVAD or mini-hyper-CVD can help to control the disease.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with documented relapsed or refractory B-cell ALL
- For newly diagnosed cohort, high-risk B-cell ALL defined by KMT2A rearrangement, complex cytogenetics, low-hypodiploidy/tetraploidy, or Philadelphia-like ALL
- Performance status of 0, 1, or 2
- Adequate organ function with creatinine 1.6 mg/dl, bilirubin 3.5 mg/dl, and ALT and AST 5 times the institutional upper limit of normal
- CD19 expression positive (>50%) before enrollment
- Participants with controlled chronic viral infections (Hepatitis B, Hepatitis C, or HIV I/II) on therapy
You will not qualify if you...
- Philadelphia positive B-cell ALL
- Pregnant or lactating women; women of child-bearing potential must have a negative pregnancy test
- Prior exposure to brexucabtagene autoleucel or other anti-CD19 CAR T-cell therapy
- Active and uncontrolled disease or infection
- Unable or unwilling to sign the consent form
- Received other investigational therapy within the past 14 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elias Jabbour, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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