A Study of ARC-02 in B-cell NHL

Part of paid clinical trials in Los Angeles, California.

Sponsor
Taiho Oncology, Inc.
Study ID
NCT07691606
Phase
PHASE1
Status
Recruiting
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Conditions

  • B-cell Non Hodgkin Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARC-02 — DRUG
    Intravenous (IV) infusion.
  • Rituximab — DRUG
    IV infusion.

Study Details

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

Key Dates

First listed
Jul 9, 2026
Start date
Jun 4, 2026
Status verified
Jul 2026
Primary completion
Jan 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
140 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A Dose Escalation: ARC-02 Monotherapy
    Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity.
  • Experimental: Part A Dose Expansion: ARC-02 Monotherapy
    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.
  • Experimental: Part B Dose Escalation: ARC-02 in Combination with Rituximab
    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.
  • Experimental: Part B Dose Expansion: ARC-02 in Combination with Rituximab
    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.

Primary Outcome Measure

Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Start CalaLos AngelesCalifornia90025-
Norton Cancer InstituteLouisvilleKentucky40202-
NYU LangoneNew YorkNew York10016-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Massey Cancer CenterRichmondVirginia23298-
Summit Cancer Centers - North SpokaneSpokaneWashington99208-
Froedtert & Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Los Angeles, CA

By research site
Start Cala· Los Angeles, CANorton Cancer Institute· Louisville, KYNYU Langone· New York, NYLevine Cancer Institute· Charlotte, NCMassey Cancer Center· Richmond, VASummit Cancer Centers - North Spokane· Spokane, WA

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