Iomab-ACT: a Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients with Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma

Eligibility Criteria

• * While prior CD19-targeted therapies, including CAR T-cell therapy, do not exclude participation, CD19 expression by immunohistochemical staining or flow cytometry must be confirmed prior to enrollment.
• * Age ≥ 18 years of age
• * Creatinine clearance ≥50 mL/min as calculated by the Cockroft-Gault formula
• * Direct bilirubin ≤2.0 mg/dL, AST and ALT ≤3.0x upper limit of normal (ULN), unless liver dysfunction is thought to be related to underlying malignancy
• * Adequate pulmonary function as assessed by ≥92% oxygen saturation on room air by pulse oximetry.
• * Adequate bone marrow function meeting the following criteria as defined below, without requiring blood product or granulocyte-colony stimulating factor support in the past 7 days, unless cytopenias are attributed to underlying malignancy in the opinion of the investigator:
• 1. Absolute neutrophil count ≥0.5k/µL,
• 2. Platelets ≥30k/µL,
• 3. Hemoglobin ≥7g/dL.
• * ECOG performance status 0-2.
• * ECOG performance status ≥3.
• * Pregnant or lactating patients. Patients of childbearing age should use effective contraception while on this study and continue for 1 year after all treatment is finished.
• * Impaired cardiac function (LVEF \<40%) as assessed by echocardiogram or MUGA scan during screening
• * Patients with active graft versus host disease following allogeneic hematopoietic cell transplantation requiring systemic T-cell suppressive therapy are ineligible
• * Patients with active autoimmune disease requiring systemic T-cell suppressive therapy are ineligible
• * Patients with following cardiac conditions will be excluded:
• 1. New York Heart Association (NYHA) stage III or IV congestive heart failure
• 2. Myocardial infarction ≤6 months prior to enrollment
• 3. Any history of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration
• 4. Any history of severe non-ischemic cardiomyopathy with LVEF ≤20%
• * Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C (HCV), with the following exceptions:
• 1. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded.
• 2. Subjects who have antibodies to HCV or who have hepatitis B core antibody, with undetectable viremia by PCR, and with adequate organ function as defined in the protocol, are not excluded.
• * Patients with uncontrolled systemic fungal, bacterial, viral or other infection are ineligible.
• * Patients with any concurrent active malignancies as defined by malignancies requiring any therapy other than expectant observation or hormonal therapy, with the exception of squamous and basal cell carcinoma of skin.
• * Patients with history or presence of clinically significant neurological disorders such as epilepsy, generalized seizure disorder, severe brain injuries are ineligible.
• * Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study.
• * Patients with circulating human anti-mouse antibodies to BC8 noted on initial screening (see Appendix III)