A Study of ARC-02 in B-cell NHL

NCT07691606
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
140
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Lead sponsor
Taiho Oncology, Inc.
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Start date
2026-06-22
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Number of sites
29
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Summary
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
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Acronym
ABLATE-101
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Short title
A Study of ARC-02 in B-cell NHL
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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)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-12-01
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First posted
2026-07-09
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Registry last updated
2026-10-08
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Primary completion date
2029-01-01
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Start date
2026-06-22
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Participants
140
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Participant count basis
Estimated
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Planned participants
140
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Protocol amendments
0
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Number of sites
29
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Taiho Oncology, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07691606
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ClinicalTrials.gov ID
NCT07691606
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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).

  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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Other registry identifiers

  • 2026-525606-35-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (7)

Targets (1)