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

Taiho Pharma

Status and phase: Enrolling; Phase 1

Conditions: B-cell Non Hodgkin Lymphoma

Treatments: Drug: ARC-02; Drug: Rituximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT07691606

ARC-02-101

2026-525606-35-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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140 participants in 4 patient groups

Part A Dose Escalation: ARC-02 Monotherapy

Experimental group

Description:

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

Treatment:

Drug: ARC-02

Part A Dose Expansion: ARC-02 Monotherapy

Experimental group

Description:

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.

Treatment:

Drug: ARC-02

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

Experimental group

Description:

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.

Treatment:

Drug: Rituximab

Drug: ARC-02

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

Experimental group

Description:

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.

Treatment:

Drug: Rituximab

Drug: ARC-02