Recruiting
Phase 1

ARC-02

Sponsor:

Taiho Oncology, Inc.

Code:

NCT07691606

Conditions

B-cell Non Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ARC-02

Rituximab

Study Details

Brief summary:

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

Conditions

B-cell Non Hodgkin Lymphoma

Study ID

NCT07691606

Start date

Jun 22, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

140 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Interventions

ARC-02

Intravenous (IV) infusion.

Rituximab

IV infusion.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Start Cala

Recruiting

Los Angeles, California, United States, 90025

Summit Cancer Centers - North Spokane

Recruiting

Spokane, Washington, United States, 99208

More Information

Sponsor

Taiho Oncology, Inc.

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Keywords

  • Non-Hodgkin's Lymphomas
  • Diffuse Large B-Cell Lymphoma
  • Mantle Cell Lymphoma
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Waldenstroms Macroglobulinemia
  • Germinal Center B-cell
  • Activated B-Cell
  • NHL
  • DLBCL
  • MCL
  • FL
  • MZL
  • WM
  • GCB
  • ABC
  • Cancer
  • ARC-02

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Taiho Oncology, Inc. on 2026-08-26.