A Study of ARC-02 in B-cell NHL

Official title

A Study to Evaluate Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity of ARC-02 in Adult Participants With B-cell Non-Hodgkins Lymphoma (NHL)

Overview

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

Interventions

• Drug ARC-02
  Intravenous (IV) infusion.
• Drug Rituximab
  IV infusion.

Primary outcome measures

• Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs) [Time frame: Up to 5 years]
• Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time frame: Up to 5 years]
• Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator [Time frame: Up to 5 years]

Secondary outcome measures (10)

• Dose Escalation: ORR as Assessed by the Investigator [Time frame: Up to 5 years]
• Dose Expansion: Number of Participants with TEAEs and SAEs [Time frame: Up to 5 years]
• Dose Escalation and Expansion: Time to Response (TTR) [Time frame: Up to 5 years]
• Dose Escalation and Expansion: Duration of Response (DOR) [Time frame: Up to 5 years]
• Dose Escalation and Expansion: Progression-free Survival (PFS) [Time frame: Up to 5 years]
• Dose Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax) [Time frame: Up to 5 years]
• Dose Escalation and Expansion: Apparent Elimination Half-Life (t½) [Time frame: Up to 5 years]
• Dose Escalation and Expansion: AUC From Time 0 to Infinity (AUC0-inf) [Time frame: Up to 5 years]
• Dose Escalation and Expansion: AUC to the Last Measurable Concentration (AUC(0-τ) [Time frame: Up to 5 years]
• Dose Escalation and Expansion: Number of Participants with Antidrug Antibodies (ADA) and Neutralizing Antibodies (Nab) [Time frame: Up to 5 years]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 7 centers

• Start Cala — Los Angeles
• Norton Cancer Institute — Louisville
• NYU Langone — New York
• Levine Cancer Institute — Charlotte
• Massey Cancer Center — Richmond
• Summit Cancer Centers - North Spokane — Spokane
• Froedtert & Medical College of Wisconsin — Milwaukee

France · 5 centers

• Hopital Henri-Mondor — Créteil
• Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Claude Huriez — Lille
• Hôpital Lyon Sud — Lyon
• CHU Nantes - Hotel Dieu — Nantes
• Institut Gustave Roussy — Villejuif

Spain · 5 centers

• Hospital Universitari Vall d'Hebron — Barcelona
• Hospital General San Pedro De Alcantara — Cáceres
• The START Center for Cancer Care - Madrid (Fundacion Jimenez Diaz) — Madrid
• START Madrid - Hospital Universitario Madrid Sanchinarro — Madrid
• Hospital Universitario Virgen del Rocio — Seville

Australia · 4 centers

• Monash Health — Clayton
• Austin Health — Melbourne
• Linear Clinical Research — Nedlands
• Gold Coast Hospital — Southport

Italy · 4 centers

• Centro di Riferimento Oncologico (CRO Aviano) — Aviano
• ASST Papa Giovanni XXIII — Bergamo
• University of Bologna — Bologna
• Istituto Clinico Humanitas — Rozzano

Poland · 4 centers

• Pratia Onkologia Katowice — Katowice
• Pratia MCM Krakow — Krakow
• Szpital AidPort — Skorzewo
• Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy — Warsaw

Identifiers

NCT: NCT07691606 · ARC-02-101 · 2026-525606-35-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗