A Study of ARC-02 in B-cell NHL
Recruiting now · Phase 1
Conditions studied: B-cell Non Hodgkin Lymphoma
In brief
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Key facts
- Study ID
- NCT07691606
- Run by
- Taiho Oncology, Inc.
- People needed
- 140
- Starts
- 2026-06-22
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2026-07-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- Summit Cancer Centers - North Spokane — Spokane, Washington, United States (enrolling)
- Start Cala — Los Angeles, California, United States (enrolling)
- NYU Langone — New York, New York, United States
- Levine Cancer Institute — Charlotte, North Carolina, United States
- Massey Cancer Center — Richmond, Virginia, United States
- Froedtert & Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Monash Health — Clayton, Australia
- Austin Health — Melbourne, Australia
- Linear Clinical Research — Nedlands, Australia
- Gold Coast Hospital — Southport, Australia
- Hopital Henri-Mondor — Créteil, France
- Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Claude Huriez — Lille, France
- Hôpital Lyon Sud — Lyon, France
- CHU Nantes - Hotel Dieu — Nantes, France
- Institut Gustave Roussy — Villejuif, France
- Centro di Riferimento Oncologico (CRO Aviano) — Aviano, Italy
- ASST Papa Giovanni XXIII — Bergamo, Italy
- University of Bologna — Bologna, Italy
- Istituto Clinico Humanitas — Rozzano, Italy
- Pratia Onkologia Katowice — Katowice, Poland
- Pratia MCM Krakow — Krakow, Poland
- Szpital AidPort — Skorzewo, Poland
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy — Warsaw, Poland
- Hospital Universitari Vall d'Hebron — Barcelona, Spain
- Hospital General San Pedro De Alcantara — Cáceres, Spain
Full record on ClinicalTrials.gov
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