A Phase 1 interventional study of ARC-02 and Rituximab in B-cell Non Hodgkin Lymphoma, sponsored by Taiho Oncology, Inc.. Recruiting at 28 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Taiho Oncology, Inc. (part of Otsuka Holdings Co., Ltd.) · Phase 1, Interventional, and Treatment
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.
This study's planned enrollment of 140 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.
Browse Lymphoma, B-Cell studies →Taiho Oncology, Inc. is the lead sponsor of 66 studies on the registry; 9 are open to participants now.
Of its 25 completed or terminated interventional studies of FDA-regulated products, 13 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
A documented diagnosis of B-cell Non- Hodgkin Lymphoma (NHL) per 2016 World Health Organization criteria and disease requiring treatment:
Exclusion Criteria:
Use of:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity.
Drug: ARC-02
Participants will receive ARC-02 at a dose determined in Part A Dose Escalation on Day 1 of each cycle until disease progression or unacceptable toxicity.
Drug: ARC-02
Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle at multiple dose levels in combination with rituximab until disease progression or unacceptable toxicity.
Drug: ARC-02 · Drug: Rituximab
Participants will receive ARC-02 at a dose determined in Part B Dose Escalation on Day 1 of each cycle in combination with rituximab until disease progression or unacceptable toxicity.
Drug: ARC-02 · Drug: Rituximab
Intravenous (IV) infusion.
IV infusion.
Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Up to 5 years
Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 5 years
Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator
Time frame: Up to 5 years
Dose Escalation: ORR as Assessed by the Investigator
Time frame: Up to 5 years
Dose Expansion: Number of Participants with TEAEs and SAEs
Time frame: Up to 5 years
Dose Escalation and Expansion: Time to Response (TTR)
Time frame: Up to 5 years
Dose Escalation and Expansion: Duration of Response (DOR)
Time frame: Up to 5 years
Dose Escalation and Expansion: Progression-free Survival (PFS)
Time frame: Up to 5 years
Dose Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax)
This will be assessed for antibody conjugated monomethyl auristatin E (acMMAE), total anti-CD79b antibody and free monomethyl auristatin E (MMAE).
Time frame: Up to 5 years
Dose Escalation and Expansion: Apparent Elimination Half-Life (t½)
This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE.
Time frame: Up to 5 years
Dose Escalation and Expansion: AUC From Time 0 to Infinity (AUC0-inf)
This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE.
Time frame: Up to 5 years
Dose Escalation and Expansion: AUC to the Last Measurable Concentration (AUC(0-τ)
This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE.
Time frame: Up to 5 years
Dose Escalation and Expansion: Number of Participants with Antidrug Antibodies (ADA) and Neutralizing Antibodies (Nab)
Time frame: Up to 5 years
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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