Clinical Trials

Key Inclusion Criteria:

- Confirmed diagnosis of one of the following:

NHL Cohorts:

1. MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after,
or was refractory to, at least one prior therapy ii. Active disease requiring
treatment

2. FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of
hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was
refractory to, at least 1 prior systemic therapy

3. DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed
after, or was refractory to, at least two prior systemic therapies and has either
progressed following or is not a candidate for autologous stem cell transplant (due to
comorbidities or non-responsiveness to salvage chemotherapy)

4. Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has
transformed into a more aggressive lymphoma. Patients with transformation from CLL or
SLL (Richter's transformation) are not eligible for Part 1

CLL/SLL Cohorts:

5. CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic
Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R
disease defined as disease that relapsed after, or was refractory to, at least 1 prior
therapy ii. Requiring treatment as defined by history

MCL cohorts:

6. WHO-defined MCL I. R/R MCL defined as disease that relapsed after, or was refractory
to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the
investigatorr

WM cohorts:

g. WHO-defined WM (clinical and definitive histologic diagnosis) i. R/R disease defined as
disease that relapsed after, or was refractory to, at least 1 prior therapy; ii. Meeting at
least 1 criterion for treatment according to consensus panel criteria from the Seventh
International Workshop on Waldenström's Macroglobulinemia (Dimopoulos et al 2014)

- Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI),
defined as:

1. CLL: at least 1 lymph node > 1.5 cm in longest diameter and measurable in 2
perpendicular dimensions or clonal lymphocytes measured by flow cytometry

2. DLBCL, FL, MZL, SLL: at least 1 lymph node > 1.5 cm in longest diameter OR 1
extranodal lesion > 1.0 cm in the longest diameter, measurable in at least 2
perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable
for this study

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Adequate organ function

- Adequate pancreatic function indicated by:

1. Serum amylase ≤ 1.5 x upper limit of normal (ULN)

2. Serum lipase ≤ 1.5 x ULN

Key Exclusion Criteria:

- Known central nervous system involvement by lymphoma/leukemia

- Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected
Richter's syndrome

- Prior therapy ≥ 2 months with or progression on a B-cell lymphoma-2 (Bcl-2) inhibitor

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 5/18/23. Questions regarding updates should be directed to the study team contact.