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

Launched by M.D. ANDERSON CANCER CENTER · Feb 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called brexucabtagene autoleucel, which is being tested in patients with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) after they have received other treatments. The aim is to see if this medication is safe and effective in helping to control the disease, especially for those with newly diagnosed high-risk B-cell ALL. Participants will be closely monitored throughout the study to ensure their safety and to gather information about how well the treatment works.

To be eligible for this trial, participants need to be at least 18 years old and have a documented diagnosis of relapsed or refractory B-cell ALL or high-risk newly diagnosed B-cell ALL. Key criteria include having a specific type of genetic profile related to their cancer and showing a certain level of health based on their organ function. Participants can expect to undergo treatment and regular check-ups, and they must be willing to sign consent for the trial. It's important to note that individuals with active infections, those who are pregnant or breastfeeding, or those who have received previous CAR T cell therapy are not eligible to participate.

Gender

ALL

Eligibility criteria

• 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