B-cell Non Hodgkin LymphomaPhase 1ABLATE-101NCT07691606
A Study of ARC-02 in B-cell NHL
A Phase 1 study testing ARC-02 and Rituximab in people with B-cell Non Hodgkin Lymphoma, run by Taiho Oncology, Inc. at 28 sites in 6 countries.
Trial summary
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Non Hodgkin Lymphoma
- What is being tested?
- ARC-02 and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 22 Jun 2026to Dec 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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).
Who cannot join
- 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.
- Use of:
- 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.
Trial locations and contacts
28 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 6 countries
United States6 sites, 6 recruiting
- Not yet recruiting
Levine Cancer Institute
Charlotte, North Carolina, 28204
- Recruiting
Start Cala
Los Angeles, California, 90025
- Not yet recruiting
Norton Cancer Institute
Louisville, Kentucky, 40202
- Not yet recruiting
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
- Not yet recruiting
Massey Cancer Center
Richmond, Virginia, 23298
- Recruiting
Summit Cancer Centers - North Spokane
Spokane, Washington, 99208
France5 sites, 5 recruiting
- Not yet recruiting
Hopital Henri-Mondor
Créteil, 94010
- Not yet recruiting
Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Claude Huriez
Lille, 59037
- Not yet recruiting
Hôpital Lyon Sud
Lyon, 69495
- Not yet recruiting
CHU Nantes - Hotel Dieu
Nantes, 44000
- Not yet recruiting
Institut Gustave Roussy
Villejuif, 94805
Spain5 sites, 5 recruiting
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 8035
- Not yet recruiting
Hospital General San Pedro De Alcantara
Cáceres, 10003
- Not yet recruiting
The START Center for Cancer Care - Madrid (Fundacion Jimenez Diaz)
Madrid, 28040
- Not yet recruiting
START Madrid - Hospital Universitario Madrid Sanchinarro
Madrid, 28050
- Not yet recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
Australia4 sites, 4 recruiting
- Not yet recruiting
Monash Health
Clayton, 3168
- Not yet recruiting
Austin Health
Melbourne, 3084
- Recruiting
Linear Clinical Research
Nedlands, 6009
- Not yet recruiting
Gold Coast Hospital
Southport, 4215
Italy4 sites, 4 recruiting
- Not yet recruiting
Centro di Riferimento Oncologico (CRO Aviano)
Aviano, 33081
- Not yet recruiting
ASST Papa Giovanni XXIII
Bergamo, 24127
- Not yet recruiting
University of Bologna
Bologna, 40138
- Not yet recruiting
Istituto Clinico Humanitas
Rozzano, 20089
Poland4 sites, 4 recruiting
- Not yet recruiting
Pratia Onkologia Katowice
Katowice, 40-519
- Not yet recruiting
Pratia MCM Krakow
Krakow, 30-727
- Not yet recruiting
Szpital AidPort
Skorzewo, 60-185
- Not yet recruiting
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
Warsaw, 02-781
About this study
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)
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
- Conditions
- B-cell Non Hodgkin Lymphoma
- Being tested
- ARC-02, Rituximab
- Keywords
- Non-Hodgkin's Lymphomas, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstroms Macroglobulinemia, Germinal Center B-cell, Activated B-Cell, NHL, DLBCL, MCL, FL, MZL, WM, GCB, ABC, Cancer, ARC-02
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Waldenstrom Macroglobulinemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-02Drug
Intravenous (IV) infusion.
RituximabDrug
IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation: ARC-02 Monotherapy | Experimental | Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity. Receives: Drug: ARC-02 |
| Part A Dose Expansion: ARC-02 Monotherapy | Experimental | 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. Receives: Drug: ARC-02 |
| Part B Dose Escalation: ARC-02 in Combination with Rituximab | Experimental | 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. Receives: Drug: ARC-02; Drug: Rituximab |
| Part B Dose Expansion: ARC-02 in Combination with Rituximab | Experimental | 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. Receives: Drug: ARC-02; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs)
Measured: Up to 5 years
Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to 5 years
Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator
Measured: Up to 5 years
Secondary outcomes (10)
Dose Escalation: ORR as Assessed by the Investigator
Measured: Up to 5 years
Dose Expansion: Number of Participants with TEAEs and SAEs
Measured: Up to 5 years
Dose Escalation and Expansion: Time to Response (TTR)
Measured: Up to 5 years
Dose Escalation and Expansion: Duration of Response (DOR)
Measured: Up to 5 years
Dose Escalation and Expansion: Progression-free Survival (PFS)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 5 years
Dose Escalation and Expansion: Number of Participants with Antidrug Antibodies (ADA) and Neutralizing Antibodies (Nab)
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start22 Jun 2026
- Primary completionJan 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691606
- Sponsor's protocol ID
- ARC-02-101
- Other IDs
- 2026-525606-35-00
- Acronym
- ABLATE-101
- Status last verified
- Oct 2026
- First submitted
- 30 Jun 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07691606
- Acronym / sponsor ID
- ABLATE-101 / ARC-02-101
- Conditions
- B-cell Non Hodgkin Lymphoma
- Keywords
- Non-Hodgkin's Lymphomas, Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Waldenstroms Macroglobulinemia, Germinal Center B-cell, Activated B-Cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation: ARC-02 Monotherapy | Experimental | Drug: ARC-02Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity. |
| Part A Dose Expansion: ARC-02 Monotherapy | Experimental | Drug: ARC-02Participants 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. |
| Part B Dose Escalation: ARC-02 in Combination with Rituximab | Experimental | Drug: ARC-02, Drug: RituximabParticipants 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. |
| Part B Dose Expansion: ARC-02 in Combination with Rituximab | Experimental | Drug: ARC-02, Drug: RituximabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- A documented diagnosis of B-cell Non- Hodgkin Lymphoma (NHL) per 2016 World Health Organization criteria and disease requiring treatment:
- 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.
Key exclusion criteria (7 listed)
- 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.
- Use of:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARC-02Intravenous (IV) infusion. | Drug | Part A Dose Escalation: ARC-02 Monotherapy, Part A Dose Expansion: ARC-02 Monotherapy, Part B Dose Escalation: ARC-02 in Combination with Rituximab, Part B Dose Expansion: ARC-02 in Combination with Rituximab |
| RituximabIV infusion. | Drug | Part B Dose Escalation: ARC-02 in Combination with Rituximab, Part B Dose Expansion: ARC-02 in Combination with Rituximab |
Primary outcome
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
10 secondary outcomes
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)
Time frame: Up to 5 years
Dose Escalation and Expansion: Apparent Elimination Half-Life (t½)
Time frame: Up to 5 years
Dose Escalation and Expansion: AUC From Time 0 to Infinity (AUC0-inf)
Time frame: Up to 5 years
Dose Escalation and Expansion: AUC to the Last Measurable Concentration (AUC(0-τ)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARC-02 and Rituximab in people with B-cell Non Hodgkin Lymphoma, run by Taiho Oncology, Inc. at 28 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, France, Spain, Australia, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Taiho Oncology, Inc. (+1 844-878-2446, medicalinformation@taihooncology.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs) (time frame: Up to 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.