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 29 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
- 29 sitesin 6 countries
- Study dates
- 22 Jun 2026to Dec 2030
- Phase
- Phase 1
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
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- 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
29 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
29 sites in 6 countries
United States7 sites, 7 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
NYU Langone
New York, New York, 10016
- 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.
- 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
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No