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A Study of ARC-02 in B-cell NHL
RecruitingPhase 1
A Study to Evaluate Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity of ARC-02 in Adult Participants With B-cell Non-Hodgkins Lymphoma (NHL)
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
What is being tested
- ARC-02 (drug)
- Rituximab (drug)
Sponsor: Taiho Oncology, Inc. · Participants: 140 · Started: Jun 22, 2026
Contact the study team
- Taiho Oncology, Inc. · Phone: +1 844-878-2446
Official record on ClinicalTrials.gov — NCT07691606
Locations in the U.S.
| California | Start Cala, Los Angeles |
| Kentucky | Norton Cancer Institute, Louisville (Not yet recruiting) |
| New York | NYU Langone, New York (Not yet recruiting) |
| North Carolina | Levine Cancer Institute, Charlotte (Not yet recruiting) |
| Virginia | Massey Cancer Center, Richmond (Not yet recruiting) |
| Washington | Summit Cancer Centers - North Spokane, Spokane |
| Wisconsin | Froedtert & Medical College of Wisconsin, Milwaukee (Not yet recruiting) |
Conditions
- B-Cell Lymphoma
- Diffuse Large B-Cell Lymphoma
- Mantle Cell Lymphoma
- Follicular Lymphoma
- Marginal Zone Lymphoma
- Waldenstrom Macroglobulinemia
- Cancer (all types)
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.