Testing ARC-02 in Adults With B-cell Non-Hodgkin Lymphoma
Tests ARC-02, with or without rituximab, in adults with B-cell non-Hodgkin lymphoma.
Key facts
- Who runs it
- Taiho Oncology, Inc.
- Where
- Charlotte, Los Angeles, Louisville, Milwaukee, Richmond, and Spokane, United StatesSee the 6 sitesAlso in 5 other countries, 22 sites
- Trial code
- Registry title
- A Study of ARC-02 in B-cell NHL
- Status
- Recruiting
- Phase
- Phase 1
- People taking part
- 140 people, planned
- Started
- 22 Jun 2026
- Expected to end
- Dec 2030
- Type of study
- Interventional, 4 groups
- Treatments tested
- ARC-02
- Rituximab
- Record updated
- 2 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with B-cell non-Hodgkin lymphoma that needs treatment and has already been treated with at least 2 earlier systemic therapies.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- B-cell non-Hodgkin lymphoma (follicular, marginal zone, mantle cell, diffuse large B-cell or other B-cell types) that can be measured and needs treatment
- Earlier treatment
- At least 2 earlier lines of systemic therapy, and no further standard treatment available
Main reasons for not taking part
- Neuropathy above Grade 1
- Past or current interstitial lung disease or pneumonitis needing treatment
- Recent chemotherapy, radiotherapy, biologic or investigational drugs within 28 days
- Live or live-attenuated vaccine within 28 days before the first dose
- Unresolved side effects from earlier cancer treatment
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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
Where in United States
Also in 5 other countries, 22 sites
- Levine Cancer InstituteCharlotte, United StatesContact: Taiho Oncology, Inc.Not yet recruiting
- Start CalaLos Angeles, United StatesContact: Taiho Oncology, Inc.Taking people
- Norton Cancer InstituteLouisville, United StatesContact: Taiho Oncology, Inc.Not yet recruiting
- Froedtert & Medical College of WisconsinMilwaukee, United StatesContact: Taiho Oncology, Inc.Not yet recruiting
- Massey Cancer CenterRichmond, United StatesContact: Taiho Oncology, Inc.Not yet recruiting
- Summit Cancer Centers - North SpokaneSpokane, United StatesContact: Taiho Oncology, Inc.Taking people
About the trial
What the trial wants to find out
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
The 4 groups in the trial
- Part A Dose Escalation: ARC-02 MonotherapyTreatment being tested
Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity.
Treatment: ARC-02
- Part A Dose Expansion: ARC-02 MonotherapyTreatment being tested
Participants will receive ARC-02 at a dose determined in Part A Dose Escalation on Day 1 of each cycle until disease progression or unacceptable toxicity.
Treatment: ARC-02
- Part B Dose Escalation: ARC-02 in Combination with RituximabTreatment being tested
Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle at multiple dose levels in combination with rituximab until disease progression or unacceptable toxicity.
Treatment: ARC-02 and Rituximab
- Part B Dose Expansion: ARC-02 in Combination with RituximabTreatment being tested
Participants will receive ARC-02 at a dose determined in Part B Dose Escalation on Day 1 of each cycle in combination with rituximab until disease progression or unacceptable toxicity.
Treatment: ARC-02 and Rituximab
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Plain-language title
- Testing ARC-02 in Adults With B-cell Non-Hodgkin LymphomaGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 2 November 2026