NCT07691606 · Taiho Oncology, Inc.
A Study of ARC-02 in B-cell NHL
(ABLATE-101)
What this study is about
This study is to assess safety, tolerability, how the drug moves through the body (PK), how the drug affects the body (PD), and preliminary effectiveness of ARC-02.
View original scientific description
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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).
Exclusion criteria
- 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.
- 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.
Where
- Los Angeles, California
- Louisville, Kentucky
- New York, New York
- Charlotte, North Carolina
- Richmond, Virginia
- Spokane, Washington
- Milwaukee, Wisconsin
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations