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)

Required: CD19 overexpression

r/r CD19+ B-ALL

Required: CD19 overexpression

aggressive CD19+ r/r B-cell NHL

Must have received: CD19-directed therapy — relapsed/refractory

confirmed by tumor biopsy tissue from last relapse after CD19-directed therapy

Cannot have received: stem cell transplant

Exception: allowed if >90 days before Screening

Participant has received stem cell transplant within 90 days before Screening

Cannot have received: CD19-directed therapy (other than autologous CD19-directed CAR T therapy)

Exception: allowed if >90 days before anticipated start date of LD

Participant has received CD19-directed therapy other than autologous CD19-directed CAR T therapy within 90 days of the anticipated start date of LD

Cannot have received: systemic biologic agent

Exception: allowed if >28 days before LD

Participant has received a systemic biologic agent for treatment of the disease under study within 28 days of LD

Cannot have received: systemic anti-cancer therapy

Exception: allowed if >10 days or 5 half-lives (whichever is shorter) before LD

other systemic anti-cancer therapy within 10 days or 5 half-lives (whichever is shorter) of LD

Cannot have received: radiotherapy

Exception: allowed if >4 weeks before Screening

Radiotherapy within 4 weeks before Screening

Cannot have received: pulse steroid for disease control

Exception: allowed if >3 days before LD

no pulse steroid for disease control within 3 days of LD