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Recruiting Phase 1

A Study of ARC-02 in B-cell NHL

NCT07691606 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2026-06-22
Last updated
2026-11-02

Condition(s) studied

B-cell Non Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

ARC-02Rituximab →

ARC-02: Intravenous (IV) infusion.

Rituximab: IV infusion.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (28)

FacilityCityRegionStatus
Start Cala Los Angeles California Recruiting
Norton Cancer Institute Louisville Kentucky Not Yet Recruiting
Levine Cancer Institute Charlotte North Carolina Not Yet Recruiting
Massey Cancer Center Richmond Virginia Not Yet Recruiting
Summit Cancer Centers - North Spokane Spokane Washington Recruiting
Froedtert & Medical College of Wisconsin Milwaukee Wisconsin Not Yet Recruiting
Monash Health Clayton Australia Not Yet Recruiting
Austin Health Melbourne Australia Not Yet Recruiting
Linear Clinical Research Nedlands Australia Recruiting
Gold Coast Hospital Southport Australia Not Yet Recruiting
Hopital Henri-Mondor Créteil France Not Yet Recruiting
Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Claude Huriez Lille France Not Yet Recruiting
Hôpital Lyon Sud Lyon France Not Yet Recruiting
CHU Nantes - Hotel Dieu Nantes France Not Yet Recruiting
Institut Gustave Roussy Villejuif France Not Yet Recruiting
Centro di Riferimento Oncologico (CRO Aviano) Aviano Italy Not Yet Recruiting
ASST Papa Giovanni XXIII Bergamo Italy Not Yet Recruiting
University of Bologna Bologna Italy Not Yet Recruiting
Istituto Clinico Humanitas Rozzano Italy Not Yet Recruiting
Pratia Onkologia Katowice Katowice Poland Not Yet Recruiting
Pratia MCM Krakow Krakow Poland Not Yet Recruiting
Szpital AidPort Skorzewo Poland Not Yet Recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy Warsaw Poland Not Yet Recruiting
Hospital Universitari Vall d'Hebron Barcelona Spain Not Yet Recruiting
Hospital General San Pedro De Alcantara Cáceres Spain Not Yet Recruiting
The START Center for Cancer Care - Madrid (Fundacion Jimenez Diaz) Madrid Spain Not Yet Recruiting
START Madrid - Hospital Universitario Madrid Sanchinarro Madrid Spain Not Yet Recruiting
Hospital Universitario Virgen del Rocio Seville Spain Not Yet Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07691606 on ClinicalTrials.gov ↗ ← All trials in the USA