ARC-02 with Rituximab for B-cell non-Hodgkin lymphomas

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial evaluates ARC-02 in combination with Rituximab for patients with various B-cell non-Hodgkin lymphomas who have exhausted standard options. It will examine safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy. Eligibility requires measurable disease, multiple prior therapies, and adequate organ function. The study is conducted at select U.S. sites including California, Kentucky, and North Carolina. Primary goals focus on safety and dosing, with secondary signals of activity guiding future development.

Why it matters

Who can join: the full rules

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.

Where it's running

• Start Cala
  Los Angeles, California, United States Recruiting
• Summit Cancer Centers - North Spokane
  Spokane, Washington, United States Recruiting
• Linear Clinical Research
  Nedlands, Australia Recruiting
• Norton Cancer Institute
  Louisville, Kentucky, United States Not yet recruiting
• Levine Cancer Institute
  Charlotte, North Carolina, United States Not yet recruiting
• Massey Cancer Center
  Richmond, Virginia, United States Not yet recruiting

Study contacts

• Study coordinator: Taiho Oncology, Inc.
• Email: medicalinformation@taihooncology.com
• Phone: +1 844-878-2446

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.