Trial to Evaluate the Safety and Efficacy of MB-102 in Patients With BPDCN.

Inclusion Criteria

• Male and female patients ≥ 18 years of age at the time of consent.
• Written informed consent in accordance with federal, local, and institutional guidelines.
• Must be able to adhere to the study visit schedule and other protocol requirements.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Meet the following laboratory criteria:
• Absolute lymphocyte count (ALC) > 100/mm3
• ALT/SGPT and AST/SGOT < 2.5x the upper limit of normal (ULN) unless due to underlying disease state
• Calculated creatinine clearance ≥ 45.0 mL/min as estimated by Cockcroft Gault and dialysis independent
• Total bilirubin ≤ 3.0 mg/dL
• Patients with Gilbert's Syndrome must have a total bilirubin < 5.0 mg/dL.
• Serum albumin ≥ 3.2 g/dL
• Cardiac ejection fraction ≥ 45%, with no evidence of pericardial effusion as determined by an echocardiogram (ECHO) or if not available, a multigated acquisition scan (MUGA).
• Females participants of childbearing potential must have a negative serum test.
• Patients must agree to use a highly effective method of contraception if procreative potential exists from the start of the study until one year after the completion of lymphodepletion for females and 4 months after completion of lymphodepletion for males.
• Patients with a previously treated malignancy if treatment of that malignancy was completed greater than 2 years before screening and the patient has no evidence of disease at the time of screening.
• Patients who have previously undergone allogenic or autologous bone marrow transplants are allowed.
• Centrally confirmed CD-123 positivity on the bone marrow, or for patients without bone marrow involvement local pathology assessments within 28 days from Screening, showing evidence of CD-123 positivity of skin/lymph node biopsy.

Exclusion Criteria

• Patients with a corticosteroid dependence on doses greater than physiological replacement i.e., prednisone no more than 7.5 mg/day or hydrocortisone less than 12mg/m2/day.
• Contraindication or hypersensitivity to fludarabine or cyclophosphamide.
• Hypersensitivity or known history of allergic reactions attributed to tocilizumab, Cetuximab, or other anti-EGFR -monoclonal antibodies.
• Immunotherapy treatments within 28 days prior to leukapheresis.
• Previous treatment with anti-CD123 CAR-T treatment.
• Previous treatment with non-CAR-T anti-CD123 agents is allowed e.g. tagraxofusp-erzs.
• Previous treatment with any other antileukemic or investigational agent within 7 days of leukapheresis.
• Hydroxyurea is allowed up to 3 days prior to leukapheresis.
• Patients with history or active seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease with CNS involvement.
• Patients with known CNS leukemic involvement that are refractory to intrathecal chemotherapy and/or cranio-spinal radiation that have NOT been effectively treated to complete remission (defined as < 5 WBC/mm3 and no blasts in CSF).
• Patients with active Graft versus Host Disease (GVHD).
• Acute active infection
• Patients being administered prophylactic antibiotics, antivirals, or antifungals are permitted.
• Patients who have any form of primary immunodeficiency, such as severe combined immunodeficiency disease, human immunodeficiency virus (HIV), or acquired immune deficiency syndrome (AIDS).
• Active infection with hepatitis B or C.
• Patients requiring supplemental oxygen or mechanical ventilation or oxygen saturation < 92% on room air.
• Patients with an oxygen saturation < 92%, a pulmonary function test with a result of Diffusing capacity of the lungs for carbon monoxide (DLCO) of ≥ 40% of predicted and a forced expiratory volume in one second (FEV1) > 45% predicted will be accepted.
• Patients with decompensated hepatic cirrhosis/liver failure.
• Pregnant or lactating females.
• Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent.