A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)

This is a Phase 1/1b, nonrandomized, open-label, parallel assignment, dose-escalation,
and dose-expansion study to evaluate the safety and clinical activity of azer-cel, an
allogeneic anti-CD19 CAR T, in adults with r/r B ALL, r/r B-cell NHL and CLL/SLL.

Key Inclusion Criteria

Criteria for B-ALL:

• Participant has confirmed unequivocal r/r CD19+ B-ALL.

Criteria for NHL and CLL/SLL:

• Participant has unequivocal aggressive CD19+ r/r B-cell NHL that is confirmed by tumor
biopsy tissue from last relapse after CD19-directed therapy.

For Phase 1 Dose Escalation:

- Diffuse large B-cell lymphoma (DLBCL) including Richter's transformation

- Follicular lymphoma (FL) including Grade 3 or transformed FL

- High-grade B-cell lymphoma (HGBCL)

- Primary mediastinal lymphoma

For Phase 1b Dose Expansion (CAR T-relapsed cohort):

- DLBCL not otherwise specified (NOS)

- HGBCL

- DLBCL transformed from the following indolent lymphoma subtypes (FL, Marginal Zone
lymphoma [MZL], and Waldenstrom's Macroglobulinemia [WM])

- Other large B-cell lymphoma (LBCL) subtypes may be enrolled with approval from the
Medical Monitor.

- Participants previously treated with CD19-directed autologous CAR T therapies have
received no more than 2 lines of therapy after administration of their previous CAR
T product.

- For the expansion CAR T-relapsed cohort only: Participants must have received
autologous CD19-directed CAR T therapy and demonstrated clinical response to the
treatment at Day 28 or later, followed by relapse or progression.

For Phase 1b dose expansion (CAR T-naive cohort):

- DLBCL NOS

- DLBCL transformed from the following indolent lymphoma subtypes (FL, MZL, and WM)

- HGBCL

- FL (Grade 1-3a)

- MZL that is fluorodeoxyglucose (FDG)-avid on positron emission tomography (PET) scan

- WM

- CLL/SLL

- Primary central nervous system (CNS) lymphoma (PCNSL)

- Other LBCL subtypes may be enrolled with approval from the Medical Monitor.

- Participant must have received at least 1-2 prior lines of therapy, depending on
histological subtype but no more than 7 systemic lines of anti-cancer therapy.

Criteria for both B-ALL, NHL, and CLL/SLL:

- Eastern Cooperative Oncology Group performance status score of 0 or 1.

- An estimated life expectancy of at least 12 weeks according to the investigator's
judgment.

- Seronegative for human immunodeficiency virus antibody.

- Participant has adequate bone marrow, renal, hepatic, pulmonary, and cardiac
function.

Key Exclusion Criteria

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.