About this trial
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 criteria
Qualifiers
Participants of age ≥18 years with documented relapsed or refractory B-cell ALL
KMT2A rearranged ALL
Complex cytogenetics as per NCCN 2022
Low-hypodiploidy/tetraploidy
Disqualifiers
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
Trial design
Treatments tested in this trial
- Blinatumomab
- Inotuzumab Ozogamicin
- Hyper-CVAD
- Mini-hyper-CVD