A Study to Evaluate Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity of ARC-02 in Adult Participants With B-cell Non-Hodgkins Lymphoma (NHL)

Study Identifier:
ARC-02-101
CT.gov Identifier:
NCT07691606
EudraCT Identifier:
202652560635
EU Trial (CTIS) Number:
2026-525606-35-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruiting

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Study Summary

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

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Lymphoma, Non-Hodgkin's
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I
Sex
Female & Male
Age
18+ years
Study Drug
Drug: EXPERIMENTAL: Part A Dose Escalation: ARC-02 Monotherapy
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Drug: Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity.
Drug: Drug: ARC-02
Drug: Intravenous (IV) infusion.
Drug: EXPERIMENTAL: Part A Dose Expansion: ARC-02 Monotherapy
Drug: 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.
Drug: EXPERIMENTAL: Part B Dose Escalation: ARC-02 in Combination with Rituximab
Drug: 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.
Drug: Drug: Rituximab
Drug: IV infusion.
Drug: EXPERIMENTAL: Part B Dose Expansion: ARC-02 in Combination with Rituximab
Drug: 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.
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting

Requirements information
Inclusion criteria
  • 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). Patients with non-Hodgkin lymphoma
Exclusion criteria
  • 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.

Clinical Study Information for Healthcare Providers

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Study Locations

Location
Investigator
Status
Condition(s) Treated at Site
Location
START Los Angeles
Los Angeles, CA, United States, 90025
Investigator
Navid Hafez
Status
Recruiting
Condition(s) Treated at Site
Lymphoma, Non-Hodgkin's