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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

Sponsor: Taiho Oncology, Inc. · Participants: 140 · Started: Jun 22, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07691606

Locations in the U.S.

CaliforniaStart Cala, Los Angeles
KentuckyNorton Cancer Institute, Louisville (Not yet recruiting)
New YorkNYU Langone, New York (Not yet recruiting)
North CarolinaLevine Cancer Institute, Charlotte (Not yet recruiting)
VirginiaMassey Cancer Center, Richmond (Not yet recruiting)
WashingtonSummit Cancer Centers - North Spokane, Spokane
WisconsinFroedtert & Medical College of Wisconsin, Milwaukee (Not yet recruiting)

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.