Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

Exclusion Criteria24

• Criteria for B-ALL:
• • Burkitt cell (L3 ALL) or mixed-lineage acute leukemia.
• Criteria for NHL:
• Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression.
• Active hemolytic anemia.
• Criteria for B-ALL and NHL:
• No active CNS disease, excluding PCNSL
• History of another primary malignancy
• Any form of primary immunodeficiency (for example, severe combined immunodeficiency disease).
• History of hepatitis B or hepatitis C currently receiving ongoing antiviral therapy.
• Any known uncontrolled cardiovascular disease at the time of Screening that, in the investigator's opinion, renders the participant ineligible
• History of hypertension crisis or hypertensive encephalopathy within 3 months prior to Screening.
• History of severe immediate hypersensitivity reaction to any of the agents used in this study.
• Presence of a CNS disorder that, in the opinion of the investigator, renders the participant ineligible for treatment.
• History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond syndrome, or any other known bone marrow failure syndrome.
• Active uncontrolled autoimmune disease requiring active immunosuppression at the time of Screening (excluding participants needing steroids for physiologic replacement).
• Participant has received stem cell transplant within 90 days before Screening.
• Participant has active graft-versus-host disease (GvHD) symptoms.
• Participant has received a systemic biologic agent for treatment of the disease under study within 28 days of LD, other systemic anti-cancer therapy within 10 days or 5 half-lives (whichever is shorter) of LD, and no pulse steroid for disease control within 3 days of LD.
• Radiotherapy within 4 weeks before Screening.
• Presence of pleural/peritoneal/pericardial catheter, as well as permeant biliary and ureteral stents (does not apply to intravenous lines).
• Participant has received live vaccine within 4 weeks before Screening. Note: Non-live virus vaccines are not excluded.
• Participant has received CD19-directed therapy other than autologous CD19-directed CAR T therapy within 90 days of the anticipated start date of LD.
• Additional criteria apply.