ClinicalTrials.gov record NCT07691606
A Study of ARC-02 in B-cell NHL
A Study to Evaluate Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity of ARC-02 in Adult Participants With B-cell Non-Hodgkins Lymphoma (NHL)
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 1 interventional study investigates ARC-02 given by IV infusion in adults with B‑cell non-Hodgkin lymphoma. Part A evaluates escalating doses and an expansion cohort of ARC-02 alone; Part B evaluates escalating doses and an expansion cohort of ARC-02 combined with rituximab. The study measures safety, drug levels (pharmacokinetics), and early signs of clinical activity.
What it is studying. The study is testing the safety and tolerability of IV ARC-02, how the drug behaves in the body (pharmacokinetics and pharmacodynamics), and whether there are early signs of anti-cancer activity when ARC-02 is given alone or together with rituximab in adults with B‑cell NHL.
What the researchers hope to learn. To find safe and tolerable dose levels of ARC-02, describe its pharmacokinetics and pharmacodynamics, assess immune response to the drug, and collect early evidence of clinical activity (objective response rate, time to response, duration of response, and progression-free survival).
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- ARC-02
- Rituximab
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive ARC-02 as an intravenous (IV) infusion on Day 1 of each treatment cycle; in Part B ARC-02 is given in combination with IV rituximab. Treatment continues cycle-by-cycle until disease progression or unacceptable toxicity. Study visits include safety checks and monitoring for side effects, and blood samples to measure drug levels (pharmacokinetics) and antidrug antibodies. Participants may join dose‑escalation groups or dose‑expansion groups and are followed and monitored for outcomes (including toxicities, responses, and PK measures) for up to 5 years.
How the study is structured. This is a Phase 1, non-randomized, open-label study with sequential parts. Part A is dose escalation followed by dose expansion of ARC-02 as a single agent. Part B is dose escalation followed by dose expansion of ARC-02 given in combination with rituximab. Participants receive ARC-02 by IV infusion on Day 1 of each treatment cycle; in Part B they also receive IV rituximab. Treatment continues until disease progression or unacceptable toxicity.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in Australia, France, Italy, Poland, Spain, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on Waldenström macroglobulinemia
Important dates
- Study start
- Jun 22, 2026
- Primary completion
- January 2029 (estimated)
- Study completion
- December 2030 (estimated)
- Target enrollment
- 140 participants (estimated)
- Last updated on registry
- Oct 8, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Taiho Oncology, Inc.
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Taiho Oncology, Inc. 📞 +1 844-878-2446 ✉ medicalinformation@taihooncology.com
Participating sites (29)
- Start CalaRecruiting
Los Angeles, California, 90025 · United States
- Norton Cancer InstituteNot Yet Recruiting
Louisville, Kentucky, 40202 · United States
- NYU LangoneNot Yet Recruiting
New York, New York, 10016 · United States
- Levine Cancer InstituteNot Yet Recruiting
Charlotte, North Carolina, 28204 · United States
- Massey Cancer CenterNot Yet Recruiting
Richmond, Virginia, 23298 · United States
- Summit Cancer Centers - North SpokaneRecruiting
Spokane, Washington, 99208 · United States
- Froedtert & Medical College of WisconsinNot Yet Recruiting
Milwaukee, Wisconsin, 53226 · United States
- Monash HealthNot Yet Recruiting
Clayton, 3168 · Australia
- Austin HealthNot Yet Recruiting
Melbourne, 3084 · Australia
- Linear Clinical ResearchRecruiting
Nedlands, 6009 · Australia
Terms used on this page · explanations by MedicalUpdates.ai
- pharmacokinetics
- How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
- pharmacodynamic
- What a drug does to the body, for example how it changes a blood marker or a symptom, and how that relates to the dose.
- prior lines
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- standard of care
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- Performance Status
- A scale from 0 to 5 that describes how a person's condition affects daily activity. 0 means fully active; 1 means restricted in strenuous activity; 2 means able to self-care but unable to work; higher numbers mean more limitation.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- women of childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- investigational product
- A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
- 5 half-lives
- The time it takes for the amount of a drug in the body to fall by half. 'Five half-lives' is often used as the point at which a previous drug has essentially left the body.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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