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
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.
- EligibilityCriteria: Inclusion Criteria:  I. Participants of age ≥18 years with documented relapsed or refractory B-cell ALL  II. In the newly diagnosed cohort: Participants of age ≥18 years with high-risk newly diagnosed B-cell ALL defined as:  KMT2A rearranged ALL Complex cytogenetics as per NCCN 2022 Low-hypodiploidy/tetraploidy Philadelphia-like ALL (based on CRLF2 overexpression or recurrent Ph-like genetic fusions)  III. Performance status of 0, 1, or 2  IV. 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  V. Participants should be CD19 expression positive (>50%) before enrollment  Exclusion Criteria  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 Known HIV-positive participants 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 - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult