Study of Brexucabtagene Autoleucel Plus Dasatinib in Adults With Acute Lymphoblastic Leukemia

Inclusion Criteria:

   - Relapsed or refractory B-precursor ALL defined as one of the following:

      - Primary refractory disease (>=5% blasts or persistent extramedullary disease
      following induction therapy)

      - First or later relapse of marrow or extramedullary disease

      - Persistence of MRD defined as detectable ALL by flow cytometry, PCR, or
      next-generation sequencing

      - Relapsed or refractory disease after allogeneic transplant provided individual is
      at least 100 days from transplant at time of enrollment

      - Patients with isolated, asymptomatic CNS relapse will be eligible

         - Age >=18 years

         - Eastern cooperative oncology group (ECOG) performance status of 0-2

         - Adequate renal, hepatic, pulmonary and cardiac function defined as:

      - Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min

      - Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x
      upper limit of normal (ULN)

      - Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilbert's syndrome.

      - Cardiac ejection fraction ≥ 50%, no evidence of clinically significant
      pericardial effusion, and no clinically significant arrhythmias

      - Baseline oxygen saturation > 92% on room air

      - QTc ≤ 500ms

         - In individuals previously treated with blinatumomab, CD19 tumor expression
         in bone marrow or peripheral blood by flow cytometry or extramedullary site
         by IHC or flow cytometry

         - Negative serum or urine beta-HCG test in females of childbearing potential
         within 3 weeks of enrollment

         - Subjects of childbearing or child fathering potential must be willing to
         practice birth control from the time of enrollment on this study Page 10 of
         83 Version 1.0 dated 27-April-2023 and for six (6) months after receiving
         the preparative conditioning regimen.

         - Must be able to give informed consent. Legal authorized representative (LAR)
         is permitted if subject is cognitively able to provide verbal assent.

Exclusion Criteria:

   - History of dasatinib intolerance

   - Known sensitivity or allergy to aminoglycosides or any agents/reagents used in this
   study

   - Blast count > 75% in the bone marrow.

   - History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g.
   cervix, bladder, breast) unless disease free for at least 2 years

   - Presence of CNS-3 disease with neurological changes

   - History or presence of any CNS disorder such as a seizure disorder, cerebrovascular
   ischemia/hemorrhage with clinical signs or symptoms

   - History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome,
   Shwachman-Diamond or any known bone marrow failure syndrome

   - History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or
   other clinically significant cardiac disease within 12 months of enrollment

   - Primary immunodeficiency

   - Known infection with HIV, hepatitis B (HBsAg positive) or untreated hepatitis C virus

   - Presence of fungal, bacterial, viral, or other infection that is uncontrolled or
   requiring IV antimicrobials for management.

   - Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment

   - Pregnant or breast feeding

   - Patients with known autoimmune disease requiring the use of systemic immunosuppressive
   therapy within the last year

   - Corticosteroid therapy within 7 days prior to enrollment

   - Acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment

   - Live vaccine ≤ 4 weeks prior to enrollment

   - Any medical condition that in the judgement of the investigator is likely to interfere
   with assessment of safety or efficacy of study treatment