Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
A Three-Arm Study of ME-401 in Subjects with Relapsed/Refractory CLL/SLL or FL, of ME-401 in
Combination with Rituximab in Subjects with Relapsed/Refractory CLL/SLL or B-cell NHL, and of
ME-401 in Combination with Zanubrutinib in Subjects with Relapsed/Refractory CLL/SLL or
B-cell NHL
Phase
Phase 1
Funding Agency/Sponsor
Industrial
Disease
Lymphoma
Enrollment Eligibility
Inclusion Criteria MEI-401 Alone:
- Diagnosis of relapsed/refractory CLL and/or relapsed/refractory SLL or FL
- No prior therapy with PI3Kd inhibitors
- No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was
intolerant of BTK therapy or subject had disease progression
- Subjects with CLL/SLL must have prior treatment with BTK inhibitor and must have had
progression or recurrence while on treatment of within 12 mos from BTK treatment
- Subject must have failed at least 1 prior systemic therapy
- QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds (ms)
- Left ventricular ejection fraction > 50%
- For subjects, except those with CLL, must have at least one bi-dimensionally
measurable nodal lesion >1.5 cm, as defined by Lugano Classification
- Willingness to participate in collection of pharmacokinetic samples
- A negative serum pregnancy test within 14 days of study Day 0, for females of
childbearing potential
Inclusion Criteria ME-401 in Combination with Rituximab
- Diagnosis of relapsed/refractory CLL SLL or FL, MZL, DLBCL and high-grade B-cell
lymphoma. Subjects must meet the following criteria for relapsed or refractory
disease:
- No prior therapy with PI3Kδ inhibitors
- No prior therapy with Bruton tyrosine kinase (BTK) inhibitors unless the subject was
intolerant of BTK therapy or subject had disease progression
- Subjects with CLL, SLL, FL, and MZL must have a failure of at least 1 prior systemic
therapy and be considered by the investigator a candidate for therapy with a
rituximab-based regimen; subjects with DLBCL and high-grade B-cell lymphoma must have
a failure of at least 2 prior therapies.
- QT-interval corrected according to Fridericia's formula (QTcF) ≤450 milliseconds (ms)
- Left ventricular ejection fraction > 50%
- For subjects, except those with CLL, must have at least one bi-dimensionally
measurable nodal lesion >1.5 cm, as defined by Lugano Classification
- Willingness to participate in collection of pharmacokinetic samples
- A negative serum pregnancy test within 14 days of study Day 0 for females of
childbearing potential
Inclusion Criteria ME-401 in Combination with Zanubrutinib
- Diagnosis of relapsed/refractory CLL or histologically-confirmed relapsed/refractory
SLL or FL, MZL, MCL, DLBCL NOS (germinal center B-cell type or activated B-cell type)
- No prior therapy with PI3Kδ inhibitors
- No prior therapy with BTK inhibitors
- Subjects with CLL, SLL, FL, MCL, and MZL must have a failure of at least 1 prior
systemic therapy, require treatment in the opinion of the investigator, and be
considered by the investigator a candidate for therapy subjects with DLBCL and
high-grade B-cell lymphoma must have a failure of at least 2 prior therapies
- For subjects with SLL, FL, MZL, MCL, DLBCL: At least one bi dimensionally measurable
nodal lesion > 1.5 cm in its longest diameter by CT scan or MRI
- QT-interval corrected according to Fridericia's formula (QTcF) ≤ 450 milliseconds
(msec)
- Left ventricular ejection fraction > 50% as measured by echocardiogram or multigated
acquisition (MUGA) scan
- Willingness to participate in collection of pharmacokinetic samples
- For females of childbearing potential, a negative serum pregnancy test within 14 days
of study Day 0
Exclusion Criteria:
- Known histological transformation from CLL to an aggressive lymphoma
- Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
- Subjects who have tested positive for hepatitis B surface antigen and/or hepatitis B
core antibody
- Positive for hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV)
antibody
- Ongoing drug-induced pneumonitis
- History of clinically significant cardiovascular abnormalities
- History of severe bleeding disorders (ME-401 plus zanubrutinib arm only)
- Known central nervous system (CNS) hemorrhage or stroke within 6 months prior to start
of study drugs (ME-401 plus zanubrutinib arm only)