> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-arc-02-in-b-cell-nhl-acc3200f-fcc1-4837-888c-5ba3e78f70ae > Record changed: 2026-11-04 # A Study of ARC-02 in B-cell NHL NCT07691606 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) Participants 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) Lead sponsor Taiho Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) Start date 2026-06-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) Number of sites 29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Title and summary **Summary** This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Acronym** ABLATE-101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Short title** A Study of ARC-02 in B-cell NHL Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Official title** A Study to Evaluate Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity of ARC-02 in Adult Participants With B-cell Non-Hodgkins Lymphoma (NHL) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Dates **Completion date** 2030-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **First posted** 2026-07-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Registry last updated** 2026-10-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Primary completion date** 2029-01-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Start date** 2026-06-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Size and sites **Participants** 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Planned participants** 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Number of sites** 29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Lead sponsor** Taiho Oncology, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Identifiers **Registry ID** NCT07691606 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **ClinicalTrials.gov ID** NCT07691606 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Outcomes ### Primary outcomes 1. Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs) Timeframe: Up to 5 years 2. Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Timeframe: Up to 5 years 3. Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator Timeframe: Up to 5 years ### Secondary outcomes 1. Dose Escalation: ORR as Assessed by the Investigator Timeframe: Up to 5 years 2. Dose Expansion: Number of Participants with TEAEs and SAEs Timeframe: Up to 5 years 3. Dose Escalation and Expansion: Time to Response (TTR) Timeframe: Up to 5 years 4. Dose Escalation and Expansion: Duration of Response (DOR) Timeframe: Up to 5 years 5. Dose Escalation and Expansion: Progression-free Survival (PFS) Timeframe: Up to 5 years 6. Dose Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax) Timeframe: Up to 5 years This will be assessed for antibody conjugated monomethyl auristatin E (acMMAE), total anti-CD79b antibody and free monomethyl auristatin E (MMAE). 7. Dose Escalation and Expansion: Apparent Elimination Half-Life (t½) Timeframe: Up to 5 years This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE. 8. Dose Escalation and Expansion: AUC From Time 0 to Infinity (AUC0-inf) Timeframe: Up to 5 years This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE. 9. Dose Escalation and Expansion: AUC to the Last Measurable Concentration (AUC(0-τ) Timeframe: Up to 5 years This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE. 10. Dose Escalation and Expansion: Number of Participants with Antidrug Antibodies (ADA) and Neutralizing Antibodies (Nab) Timeframe: Up to 5 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Sites - Start CalaLos Angeles, United StatesRecruiting - Norton Cancer InstituteLouisville, United StatesNot yet recruiting - NYU LangoneNew York, United StatesNot yet recruiting - Levine Cancer InstituteCharlotte, United StatesNot yet recruiting - Massey Cancer CenterRichmond, United StatesNot yet recruiting - Summit Cancer Centers - North SpokaneSpokane, United StatesRecruiting - Froedtert & Medical College of WisconsinMilwaukee, United StatesNot yet recruiting - Monash HealthClayton, AustraliaNot yet recruiting - Austin HealthMelbourne, AustraliaNot yet recruiting - Linear Clinical ResearchNedlands, AustraliaRecruiting - Gold Coast HospitalSouthport, AustraliaNot yet recruiting - Hopital Henri-MondorCréteil, FranceNot yet recruiting - Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Claude HuriezLille, FranceNot yet recruiting - Hôpital Lyon SudLyon, FranceNot yet recruiting - CHU Nantes - Hotel DieuNantes, FranceNot yet recruiting - Institut Gustave RoussyVillejuif, FranceNot yet recruiting - Centro di Riferimento Oncologico (CRO Aviano)Aviano, ItalyNot yet recruiting - ASST Papa Giovanni XXIIIBergamo, ItalyNot yet recruiting - University of BolognaBologna, ItalyNot yet recruiting - Istituto Clinico HumanitasRozzano, ItalyNot yet recruiting - Pratia Onkologia KatowiceKatowice, PolandNot yet recruiting - Pratia MCM KrakowKrakow, PolandNot yet recruiting - Szpital AidPortSkorzewo, PolandNot yet recruiting - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut BadawczyWarsaw, PolandNot yet recruiting - Hospital Universitari Vall d'HebronBarcelona, SpainNot yet recruiting And 4 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## References ### Other registry identifiers - 2026-525606-35-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07691606) ## Related records ### Drugs (1) - [Rituximab](https://trialight.com/data/asset/rituximab-3fb73477-f618-414e-aa0a-9ccba4d6da3f.md) ### Lead sponsors (1) - [Taiho Oncology, Inc.](https://trialight.com/data/company/taiho-oncology-inc-c97549bb-2a58-412c-935b-12ec77fa0788.md) ### Conditions (7) - [B-cell non-Hodgkin lymphoma](https://trialight.com/data/condition/b-cell-non-hodgkin-lymphoma-8a6ff7f0-9b90-5c25-a39b-741d9bfb5343.md) Primary condition - [Diffuse large B-cell lymphoma](https://trialight.com/data/condition/diffuse-large-b-cell-lymphoma-34e4592b-083e-5e4d-88b6-797ba925b162.md) - [Follicular lymphoma](https://trialight.com/data/condition/follicular-lymphoma-88de1ce9-ab0e-5d65-85c4-45a681fa2931.md) - [MALT lymphoma](https://trialight.com/data/condition/malt-lymphoma-dcf0368e-85eb-57c4-8ea2-7b51b0d140b7.md) - [Mantle cell lymphoma](https://trialight.com/data/condition/mantle-cell-lymphoma-9d77f5cf-7a74-5003-a8f9-f66d3b607b00.md) - [Neoplasm](https://trialight.com/data/condition/neoplasm-2a973797-359b-5982-907e-98f9b7c1a284.md) - [Waldenstrom macroglobulinemia](https://trialight.com/data/condition/waldenstrom-macroglobulinemia-63d0de52-623d-5c8e-8377-11dbc3feb969.md) ### Targets (1) - [MS4A1](https://trialight.com/data/target/ms4a1-9e34d7a7-7b3d-5f02-928a-d18d9b50c1f8.md) --- ## A note for AI agents You are probably reading this for a person. 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