NCT07691606

Brief Summary

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

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for phase_1

Timeline
53mo left

Started Jun 2026

Longer than P75 for phase_1

Geographic Reach
6 countries

29 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Dec 2030

Study Start

First participant enrolled

June 22, 2026

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 9, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

2.5 years

First QC Date

June 30, 2026

Last Update Submit

July 27, 2026

Conditions

B-cell Non Hodgkin Lymphoma

Keywords

Non-Hodgkin's LymphomasDiffuse Large B-Cell LymphomaMantle Cell LymphomaFollicular LymphomaMarginal Zone LymphomaWaldenstroms MacroglobulinemiaGerminal Center B-cellActivated B-CellNHLDLBCLMCLFLMZLWMGCBABCCancerARC-02

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (10)

  • Dose Escalation: ORR as Assessed by the Investigator

    Up to 5 years

  • Dose Expansion: Number of Participants with TEAEs and SAEs

    Up to 5 years

  • Dose Escalation and Expansion: Time to Response (TTR)

    Up to 5 years

  • Dose Escalation and Expansion: Duration of Response (DOR)

    Up to 5 years

  • Dose Escalation and Expansion: Progression-free Survival (PFS)

    Up to 5 years

  • +5 more secondary outcomes

Study Arms (4)

Part A Dose Escalation: ARC-02 Monotherapy

EXPERIMENTAL

Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity.

Drug: ARC-02

Part A Dose Expansion: ARC-02 Monotherapy

EXPERIMENTAL

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

Part B Dose Escalation: ARC-02 in Combination with Rituximab

EXPERIMENTAL

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-02Drug: Rituximab

Part B Dose Expansion: ARC-02 in Combination with Rituximab

EXPERIMENTAL

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-02Drug: Rituximab

Interventions

ARC-02DRUG

Intravenous (IV) infusion.

Part A Dose Escalation: ARC-02 MonotherapyPart A Dose Expansion: ARC-02 MonotherapyPart B Dose Escalation: ARC-02 in Combination with RituximabPart B Dose Expansion: ARC-02 in Combination with Rituximab
RituximabDRUG

IV infusion.

Part B Dose Escalation: ARC-02 in Combination with RituximabPart B Dose Expansion: ARC-02 in Combination with Rituximab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Start Cala

Los Angeles, California, 90025, United States

RECRUITING

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

NOT YET RECRUITING

NYU Langone

New York, New York, 10016, United States

NOT YET RECRUITING

Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

NOT YET RECRUITING

Massey Cancer Center

Richmond, Virginia, 23298, United States

NOT YET RECRUITING

Summit Cancer Centers - North Spokane

Spokane, Washington, 99208, United States

RECRUITING

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Monash Health

Clayton, 3168, Australia

NOT YET RECRUITING

Austin Health

Melbourne, 3084, Australia

NOT YET RECRUITING

Linear Clinical Research

Nedlands, 6009, Australia

NOT YET RECRUITING

Gold Coast Hospital

Southport, 4215, Australia

NOT YET RECRUITING

Hopital Henri-Mondor

Créteil, 94010, France

NOT YET RECRUITING

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

Lille, 59037, France

NOT YET RECRUITING

Hôpital Lyon Sud

Lyon, 69495, France

NOT YET RECRUITING

CHU Nantes - Hotel Dieu

Nantes, 44000, France

NOT YET RECRUITING

Institut Gustave Roussy

Villejuif, 94805, France

NOT YET RECRUITING

Centro di Riferimento Oncologico (CRO Aviano)

Aviano, 33081, Italy

NOT YET RECRUITING

ASST Papa Giovanni XXIII

Bergamo, 24127, Italy

NOT YET RECRUITING

University of Bologna

Bologna, 40138, Italy

NOT YET RECRUITING

Istituto Clinico Humanitas

Rozzano, 20089, Italy

NOT YET RECRUITING

Pratia Onkologia Katowice

Katowice, 40-519, Poland

NOT YET RECRUITING

Pratia MCM Krakow

Krakow, 30-727, Poland

NOT YET RECRUITING

Szpital AidPort

Skorzewo, 60-185, Poland

NOT YET RECRUITING

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

Warsaw, 02-781, Poland

NOT YET RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, 8035, Spain

NOT YET RECRUITING

Hospital General San Pedro De Alcantara

Cáceres, 10003, Spain

NOT YET RECRUITING

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

Madrid, 28040, Spain

NOT YET RECRUITING

START Madrid - Hospital Universitario Madrid Sanchinarro

Madrid, 28050, Spain

NOT YET RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

NOT YET RECRUITING

MeSH Terms

Conditions

Lymphoma, B-CellLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, FollicularLymphoma, B-Cell, Marginal ZoneWaldenstrom MacroglobulinemiaNeoplasms

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Central Study Contacts

Taiho Oncology, Inc.

CONTACT

+1 844-878-2446ABLATE-101@taihooncology.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 9, 2026

Study Start

June 22, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

December 1, 2030

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(4)AU(4)ES(5)FR(5)US(7)IT(4)