A Study of ARC-02 in B-cell NHL (ABLATE-101)

July 8, 2026 updated by: Taiho Oncology, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Clayton, Australia, 3168
        • Not yet recruiting
        • Monash Health
      • Melbourne, Australia, 3084
        • Not yet recruiting
        • Austin Health
      • Nedlands, Australia, 6009
        • Not yet recruiting
        • Linear Clinical Research
      • Southport, Australia, 4215
        • Not yet recruiting
        • Gold Coast Hospital
  • France
      • Créteil, France, 94010
        • Not yet recruiting
        • Hopital Henri-Mondor
      • Lille, France, 59037
        • Not yet recruiting
        • Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Claude Huriez
      • Lyon, France, 69495
        • Not yet recruiting
        • Hôpital Lyon Sud
      • Nantes, France, 44000
        • Not yet recruiting
        • CHU Nantes - Hotel Dieu
      • Villejuif, France, 94805
        • Not yet recruiting
        • Institut Gustave Roussy
  • Italy
      • Aviano, Italy, 33081
        • Not yet recruiting
        • Centro di Riferimento Oncologico (CRO Aviano)
      • Bergamo, Italy, 24127
        • Not yet recruiting
        • ASST Papa Giovanni XXIII
      • Bologna, Italy, 40138
        • Not yet recruiting
        • University of Bologna
      • Rozzano, Italy, 20089
        • Not yet recruiting
        • Istituto Clinico Humanitas
  • Poland
      • Katowice, Poland, 40-519
        • Not yet recruiting
        • Pratia Onkologia Katowice
      • Krakow, Poland, 30-727
        • Not yet recruiting
        • Pratia MCM Krakow
      • Skorzewo, Poland, 60-185
        • Not yet recruiting
        • Szpital AidPort
      • Warsaw, Poland, 02-781
        • Not yet recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
  • Spain
      • Barcelona, Spain, 8035
        • Not yet recruiting
        • Hospital Universitari Vall d'Hebron
      • Cáceres, Spain, 10003
        • Not yet recruiting
        • Hospital General San Pedro De Alcantara
      • Madrid, Spain, 28040
        • Not yet recruiting
        • The START Center for Cancer Care - Madrid (Fundacion Jimenez Diaz)
      • Madrid, Spain, 28050
        • Not yet recruiting
        • START Madrid - Hospital Universitario Madrid Sanchinarro
      • Seville, Spain, 41013
        • Not yet recruiting
        • Hospital Universitario Virgen del Rocio
  • United States
    • California
      • Los Angeles, California, United States, 90025
        • Recruiting
        • Start Cala
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Not yet recruiting
        • Norton Cancer Institute
    • New York
      • New York, New York, United States, 10016
        • Not yet recruiting
        • NYU Langone
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Not yet recruiting
        • Levine Cancer Institute
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Not yet recruiting
        • Massey Cancer Center
    • Washington
      • Spokane, Washington, United States, 99208
        • Recruiting
        • Summit Cancer Centers - North Spokane
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Froedtert & Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A Dose Escalation: ARC-02 Monotherapy
Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity.
Drug: ARC-02
Intravenous (IV) infusion.
Experimental: Part A Dose Expansion: ARC-02 Monotherapy
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.
Drug: ARC-02
Intravenous (IV) infusion.
Experimental: Part B Dose Escalation: ARC-02 in Combination with Rituximab
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.
Drug: ARC-02
Intravenous (IV) infusion.
Drug: Rituximab
IV infusion.
Experimental: Part B Dose Expansion: ARC-02 in Combination with Rituximab
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.
Drug: ARC-02
Intravenous (IV) infusion.
Drug: Rituximab
IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time Frame: Up to 5 years
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
Up to 5 years
Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose Escalation: ORR as Assessed by the Investigator
Time Frame: Up to 5 years
Up to 5 years
Dose Expansion: Number of Participants with TEAEs and SAEs
Time Frame: Up to 5 years
Up to 5 years
Dose Escalation and Expansion: Time to Response (TTR)
Time Frame: Up to 5 years
Up to 5 years
Dose Escalation and Expansion: Duration of Response (DOR)
Time Frame: Up to 5 years
Up to 5 years
Dose Escalation and Expansion: Progression-free Survival (PFS)
Time Frame: Up to 5 years
Up to 5 years
Dose Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax)
Time Frame: Up to 5 years
This will be assessed for antibody conjugated monomethyl auristatin E (acMMAE), total anti-CD79b antibody and free monomethyl auristatin E (MMAE).
Up to 5 years
Dose Escalation and Expansion: Apparent Elimination Half-Life (t½)
Time Frame: Up to 5 years
This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE.
Up to 5 years
Dose Escalation and Expansion: AUC From Time 0 to Infinity (AUC0-inf)
Time Frame: Up to 5 years
This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE.
Up to 5 years
Dose Escalation and Expansion: AUC to the Last Measurable Concentration (AUC(0-τ)
Time Frame: Up to 5 years
This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE.
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
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taiho Oncology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

June 30, 2026

First Submitted That Met QC Criteria

July 8, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARC-02-101
  • 2026-525606-35-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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