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New drug combo aims to tackle Hard-to-Treat lymphoma

NCT ID NCT07691606

Disease control Sponsor: Taiho Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Aug 27, 2026 · Updated 5 times

Summary

This study tests a new drug called ARC-02, given together with rituximab, in adults with B-cell non-Hodgkin lymphoma whose cancer has not responded to at least two prior treatments. The main goals are to check the safety of ARC-02 and find the best dose, while also looking at whether it can shrink tumors. The trial is early-stage, so it focuses on side effects and how the drug moves through the body, not yet on a cure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ARC-02 (given by IV infusion) plus rituximab
What this could lead to
If successful, this could provide a new treatment option for people with B-cell non-Hodgkin lymphoma who have not responded to other therapies.
What could go wrong
This is an early-phase trial focused on safety and dosing, so it is not yet known whether ARC-02 will effectively shrink tumors or improve outcomes. Side effects are possible and will be closely monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

B-cell neoplasm B-cell non-Hodgkin lymphoma diffuse large B-cell lymphoma follicular lymphoma Lymphoma, B-Cell, Marginal Zone mantle cell lymphoma marginal zone lymphoma neoplasm Waldenstrom macroglobulinemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

B-cell non Hodgkin lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    29 sites in 6 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ASST Papa Giovanni XXIII

    NOT_YET_RECRUITING

    Bergamo, 24127, Italy

  • Austin Health

    NOT_YET_RECRUITING

    Melbourne, 3084, Australia

  • CHU Nantes - Hotel Dieu

    NOT_YET_RECRUITING

    Nantes, 44000, France

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

    NOT_YET_RECRUITING

    Lille, 59037, France

  • Centro di Riferimento Oncologico (CRO Aviano)

    NOT_YET_RECRUITING

    Aviano, 33081, Italy

  • Froedtert & Medical College of Wisconsin

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Gold Coast Hospital

    NOT_YET_RECRUITING

    Southport, 4215, Australia

  • Hopital Henri-Mondor

    NOT_YET_RECRUITING

    Créteil, 94010, France

  • Hospital General San Pedro De Alcantara

    NOT_YET_RECRUITING

    Cáceres, 10003, Spain

  • Hospital Universitari Vall d'Hebron

    NOT_YET_RECRUITING

    Barcelona, 8035, Spain

  • Hospital Universitario Virgen del Rocio

    NOT_YET_RECRUITING

    Seville, 41013, Spain

  • Hôpital Lyon Sud

    NOT_YET_RECRUITING

    Lyon, 69495, France

  • Institut Gustave Roussy

    NOT_YET_RECRUITING

    Villejuif, 94805, France

  • Istituto Clinico Humanitas

    NOT_YET_RECRUITING

    Rozzano, 20089, Italy

  • Levine Cancer Institute

    NOT_YET_RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Linear Clinical Research

    NOT_YET_RECRUITING

    Nedlands, 6009, Australia

  • Massey Cancer Center

    NOT_YET_RECRUITING

    Richmond, Virginia, 23298, United States

  • Monash Health

    NOT_YET_RECRUITING

    Clayton, 3168, Australia

  • NYU Langone

    NOT_YET_RECRUITING

    New York, New York, 10016, United States

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

    NOT_YET_RECRUITING

    Warsaw, 02-781, Poland

  • Norton Cancer Institute

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40202, United States

  • Pratia MCM Krakow

    NOT_YET_RECRUITING

    Krakow, 30-727, Poland

  • Pratia Onkologia Katowice

    NOT_YET_RECRUITING

    Katowice, 40-519, Poland

  • START Madrid - Hospital Universitario Madrid Sanchinarro

    NOT_YET_RECRUITING

    Madrid, 28050, Spain

  • Start Cala

    RECRUITING

    Los Angeles, California, 90025, United States

  • Summit Cancer Centers - North Spokane

    RECRUITING

    Spokane, Washington, 99208, United States

  • Szpital AidPort

    NOT_YET_RECRUITING

    Skorzewo, 60-185, Poland

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

    NOT_YET_RECRUITING

    Madrid, 28040, Spain

  • University of Bologna

    NOT_YET_RECRUITING

    Bologna, 40138, Italy

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