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

Summary

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.

Eligibility

Inclusion Criteria:

* 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:

  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)
* 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 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
* 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

Conditions3

Locations1 site

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