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Recruiting

NCT Number: NCT07691606

A Study of ARC-02 in B-cell NHL

This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

ARC-02

Drug

Intravenous (IV) infusion.

Rituximab

Drug

IV infusion.

Primary outcomes

  1. Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs)

    Time frame: Up to 5 years

  2. Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 5 years

  3. Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator

    Time frame: Up to 5 years

Secondary outcomes

  1. Dose Escalation: ORR as Assessed by the Investigator

    Time frame: Up to 5 years

  2. Dose Expansion: Number of Participants with TEAEs and SAEs

    Time frame: Up to 5 years

  3. Dose Escalation and Expansion: Time to Response (TTR)

    Time frame: Up to 5 years

  4. Dose Escalation and Expansion: Duration of Response (DOR)

    Time frame: Up to 5 years

  5. Dose Escalation and Expansion: Progression-free Survival (PFS)

    Time frame: Up to 5 years

  6. Dose Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Up to 5 years

Study contacts

Contact information is provided by the study sponsor or research team.

Taiho Oncology, Inc.

CONTACT

[email protected]

+1 844-878-2446

Sponsors and collaborators

Lead sponsor

Taiho Oncology, Inc.

Industry

Registry information

Official study 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)

Acronym: ABLATE-101

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jul 9, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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