Overview
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Eligibility
Inclusion Criteria:
- A documented diagnosis of B-cell Non- Hodgkin Lymphoma (NHL) per 2016 World Health Organization criteria and disease requiring treatment:
- Follicular lymphoma (FL), Grades 1 through 3B
- Marginal zone lymphoma (MZL)
- Mantle cell lymphoma (MCL)
- Diffuse large B-cell lymphoma (DLBCL)
- Other B-cell NHL
- Measurable disease.
- Received at least 2 prior lines of systemic therapies and not eligible to receive additional standard of care therapies.
- An Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at screening.
- Adequate organ function within 3 days of the first dose of study intervention.
- A negative blood pregnancy test within 7 days prior to first dose of study intervention (for women of childbearing potential).
Exclusion Criteria:
- Receiving an investigational product or participating in any other type of medical research judged not to be compatible with this study.
- Grade \> 1 neuropathy
- History of interstitial lung disease (ILD)/pneumonitis requiring treatment or any evidence of active ILD/pneumonitis.
- Use of:
- Chemotherapy, radiotherapy, small molecule, investigational, and biologic agents (including CD79b-directed agents) within 28 days (or at least 5 half-lives, whichever is shorter), prior to the first dose of the study intervention.
- Any live or live-attenuated vaccine within 28 days before the first dose of the study intervention.
- Ongoing clinically relevant toxicity from prior anticancer therapy that has not resolved to Grade ≤ 2 (neutropenia) or Grade ≤ 1 (thrombocytopenia or nonhematologic toxicities), with the exception of alopecia.


