A Study of ARC-02 in B-cell NHL

Summary

This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.

Eligibility

Inclusion Criteria:

1. A documented diagnosis of B-cell Non- Hodgkin Lymphoma (NHL) per 2016 World Health Organization criteria and disease requiring treatment:

   1. Follicular lymphoma (FL), Grades 1 through 3B
   2. Marginal zone lymphoma (MZL)
   3. Mantle cell lymphoma (MCL)
   4. Diffuse large B-cell lymphoma (DLBCL)
   5. Other B-cell NHL
2. Measurable disease.
3. Received at least 2 prior lines of systemic therapies and not eligible to receive additional standard of care therapies.
4. An Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at screening.
5. Adequate organ function within 3 days of the first dose of study intervention.
6. A negative blood pregnancy test within 7 days prior to first dose of study intervention (for women of childbearing potential).

Exclusion Criteria:

1. Receiving an investigational product or participating in any other type of medical research judged not to be compatible with this study.
2. Grade \> 1 neuropathy
3. History of interstitial lung disease (ILD)/pneumonitis requiring treatment or any evidence of active ILD/pneumonitis.
4. Use of:

   1. 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.
   2. Any live or live-attenuated vaccine within 28 days before the first dose of the study intervention.
5. 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.

Conditions2

Interventions2

Locations7 sites

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