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A Study of ARC-02 in B-cell NHL

ConditionB-cell Non Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaiho Oncology, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Follicular lymphoma (FL), Grades 1 through 3B

Marginal zone lymphoma (MZL)

Mantle cell lymphoma (MCL)

Diffuse large B-cell lymphoma (DLBCL)

Disqualifiers

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.

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ARC-02

    Drug

    Intravenous (IV) infusion.

  • Rituximab

    Drug

    IV infusion.

Treatment groups

140 Participants
are divided into 4 treatment groups
Group A: Part A Dose Escalation: ARC-02 MonotherapyExperimental treatment 1 intervention
Group B: Part A Dose Expansion: ARC-02 MonotherapyExperimental treatment 1 intervention
Group C: Part B Dose Escalation: ARC-02 in Combination with RituximabExperimental treatment 2 interventions
Group D: Part B Dose Expansion: ARC-02 in Combination with RituximabExperimental treatment 2 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Taiho Oncology, Inc.

Lead sponsor

Source ClinicalTrials.gov
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