A Study of ARC-02 in B-cell NHL
Key facts
- Where
- Aviano, Bergamo, Bologna, and Rozzano, ItalySee the 4 sites
- Phase
- Phase 1
Where in Italy
- Centro di Riferimento Oncologico di AvianoAviano, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere ScientificoBologna, ItalyNot yet recruiting
- Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Taiho Oncology, Inc.
- Trial code
- NCT07691606EU 2026-525606-35-00
- Record updated
- 2 November 2026
- Original description
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.Read full original descriptionShow less
A Study to Evaluate Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity of ARC-02 in Adult Participants With B-cell Non-Hodgkins Lymphoma (NHL)
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Inclusion: 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: 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; History of interstitial lung disease (ILD)/pneumonitis requiring treatment or any evidence of active ILD/pneumonitis; Grade > 1 neuropathy.