A Study of ARC-02 in B-cell NHL

Prior treatment

• Receiving an investigational product or participating in any other type of medical research judged not to be compatible with this study.
• 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.

Other illness

• History of interstitial lung disease (ILD)/pneumonitis requiring treatment or any evidence of active ILD/pneumonitis.

Other

• Grade \> 1 neuropathy

• 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).