Ensayos clínicos

Main Inclusion Criteria:

- Signed and dated informed consent, and able to comply with the study procedures and
any locally required authorization.

- Male or female aged ≥ 18 years.

- Relapsed/refractory patients with histologically confirmed diagnosis of B cell or T
cell lymphoma

- Must have received at least 2 prior systemic therapies and have no treatment options
known to provide clinical benefit

- Must have measurable disease per Lugano lymphoma classification except for cutaneous
T-cell lymphoma (CTCL) which is measured via International Society for Cutaneous
Lymphomas (ISCL)/ European Organization of Research and Treatment of Cancer (EORTC).

- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

- Life expectancy > 3 months as assessed by the Investigator.

- Adequate organ function (bone marrow, hepatic, renal function and coagulation).

- All toxicities (except alopecia) from prior cancer treatments or procedures must have
resolved to ≤Grade 1 or returned to baseline levels prior to enrollment.

Main Exclusion Criteria:

- Pregnant or breastfeeding females and women of child bearing potential or males
unwilling to comply with contraception requirements.

- Known carcinomatous meningitis or central nervous system (CNS) involvement with
lymphoma.

- Active malignancy within 2 years of study enrollment

- Prior radiation or surgical resection of their lymphoma without additional sites of
measurable disease outside of the radiation field or subjects who have received prior
radiation or surgical resection of their lymphoma ≤2 weeks prior to the first dose of
study drug.

- Systemic cancer treatments, monoclonal antibody-directed therapies, other
investigational agents within 4 weeks before enrollment, or <5 half-lives since
completion of previous investigational therapy, whichever is shorter.

- Uncontrolled intercurrent illness.

- Immunocompromised subjects with increased risk of opportunistic infections or history
of opportunistic infection in the last 12 months.

- Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection.

- Subjects who have received a live vaccine within 30 days prior to study enrollment or
whilst participating in the study.

- Subjects with corrected QT interval > 470 msec based on averaged triplicate
electrocardiogram (ECG) readings at the Screening Visit using the QT interval
corrected for heart rate using Fridericia's method (QTcF).

- Subjects who received a severe acute respiratory syndrome coronavirus 2 vaccine ≤ 3
weeks prior to study drug dosing.

Eligibility last updated 8/9/23. Questions regarding updates should be directed to the study team contact.