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NCT07691606PHASE1Recruiting

A Study of ARC-02 in B-cell NHL

Taiho Oncology, Inc.

Start Date

6/22/2026

Completion Date

12/1/2030

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

ARC-02

DRUG

Rituximab

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Conditions

B-cell Non Hodgkin Lymphoma

Locations

Start Cala

Los Angeles, California 90025

United States

Norton Cancer Institute

Louisville, Kentucky 40202

United States

NYU Langone

New York, New York 10016

United States

Levine Cancer Institute

Charlotte, North Carolina 28204

United States

Massey Cancer Center

Richmond, Virginia 23298

United States

Summit Cancer Centers - North Spokane

Spokane, Washington 99208

United States

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Monash Health

Clayton, 3168

Australia

Austin Health

Melbourne, 3084

Australia

Linear Clinical Research

Nedlands, 6009

Australia

Gold Coast Hospital

Southport, 4215

Australia

Hopital Henri-Mondor

Créteil, 94010

France

Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Claude Huriez

Lille, 59037

France

Hôpital Lyon Sud

Lyon, 69495

France

CHU Nantes - Hotel Dieu

Nantes, 44000

France

Institut Gustave Roussy

Villejuif, 94805

France

Centro di Riferimento Oncologico (CRO Aviano)

Aviano, 33081

Italy

ASST Papa Giovanni XXIII

Bergamo, 24127

Italy

University of Bologna

Bologna, 40138

Italy

Istituto Clinico Humanitas

Rozzano, 20089

Italy

Pratia Onkologia Katowice

Katowice, 40-519

Poland

Pratia MCM Krakow

Krakow, 30-727

Poland

Szpital AidPort

Skorzewo, 60-185

Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

Warsaw, 02-781

Poland

Hospital Universitari Vall d'Hebron

Barcelona, 8035

Spain

Hospital General San Pedro De Alcantara

Cáceres, 10003

Spain

The START Center for Cancer Care - Madrid (Fundacion Jimenez Diaz)

Madrid, 28040

Spain

START Madrid - Hospital Universitario Madrid Sanchinarro

Madrid, 28050

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain