NCT07691606 A Study of ARC-02 in B-cell NHL
| NCT ID | NCT07691606 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Taiho Oncology, Inc. |
| Condition | B-cell Non Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2026-06-04 |
| Primary Completion | 2029-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 140 participants in total. It began in 2026-06-04 with a primary completion date of 2029-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07691606 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying B-cell Non Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07691606 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07691606 currently recruiting?
Yes, NCT07691606 is actively recruiting participants. Contact the research team at ABLATE-101@taihooncology.com for enrollment information.
Where is the NCT07691606 trial being conducted?
This trial is being conducted at Los Angeles, United States, Louisville, United States, New York, United States, Charlotte, United States and 11 additional locations.
Who is sponsoring the NCT07691606 clinical trial?
NCT07691606 is sponsored by Taiho Oncology, Inc.. The trial plans to enroll 140 participants.