Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria :
1. Provision of signed and dated written informed consent prior to any study-specific
procedures, sampling, or data collection
2. Age ≥ 18 years
3. Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise
noted) of one of the following: MZL (Part 1a and 1b only), FL (Part 1a only), MCL,
CLL/SLL, WM (Part 1a and 1b only), DLBCL (Part 1a only), or >2 treatments per the
Richter's transformation to DLBCL (Part 1a only).
4. Patients who have previously received a covalently-binding BTK inhibitor in any line
of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless
reason for discontinuation is intolerance).
5. For dose-finding and dose-expansion, patients who had previously received a
covalently-binding BTK inhibitor as monotherapy or in combination with other
anticancer agents are eligible for the study if they meet any of the following
criteria: discontinued the previous BTK inhibitor due to disease progression,
experienced disease progression after completing treatment with a BTK inhibitor or
discontinued the BTK inhibitor due to toxicity or intolerance.
6. Measurable disease by radiographic assessment or serum IgM level (WM only)
7. ECOG Performance Status of 0 to 2
8. Patients enrolling in the dose finding phase of the study may be previously treated
with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of
enrollment; patients with CLL/SLL or MCL enrolling in the expansion cohorts (Part 2)
must have been treated with a BTKi in a prior line of therapy.
1. Prior malignancy (other than the disease under study) within the past 2 years, except
for curatively treated basal or squamous skin cancer, superficial bladder cancer,
carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate
2. Requires ongoing systemic treatment for any other malignancy
3. Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent)
4. Current or history of central nervous system involvement including the brain, spinal
cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or
biopsy) by B-cell malignancy, regardless of whether patient had received treatment for
central nervous system disease
5. Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt
lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman
disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, GCB
DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary
cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary
mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+
large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC
and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma
unclassifiable with features intermediate between DLBCL and classical Hodgkin
lymphoma, or history of or currently suspected Richter's transformation of an indolent
lymphoma to an aggressive histology (only patients with Richter Transformation to
DLBCL are eligible for Part 1a).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 5/19/23. Questions regarding updates should be directed to the study team contact.