Clinical Trials in the USA / NCT07691606
Recruiting
Phase 1
A Study of ARC-02 in B-cell NHL
NCT07691606 · tracked via the Priya Life Science USA tracker
Condition(s) studied
B-cell Non Hodgkin Lymphoma
Investigational drug(s) / intervention(s)
ARC-02Rituximab →
ARC-02: Intravenous (IV) infusion.
Rituximab: IV infusion.
Study summary
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Eligibility
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).
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.
Primary outcome measure(s)
- Dose Escalation: Number of Participants with Dose-Limiting Toxicities (DLTs) — Up to 5 years
- Dose Escalation: Number of Participants with Treatment- Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — Up to 5 years
- Dose Expansion: Objective Response Rate (ORR) as Assessed by the Investigator — Up to 5 years
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| Start Cala | Los Angeles | California | Recruiting |
| Norton Cancer Institute | Louisville | Kentucky | Not Yet Recruiting |
| Levine Cancer Institute | Charlotte | North Carolina | Not Yet Recruiting |
| Massey Cancer Center | Richmond | Virginia | Not Yet Recruiting |
| Summit Cancer Centers - North Spokane | Spokane | Washington | Recruiting |
| Froedtert & Medical College of Wisconsin | Milwaukee | Wisconsin | Not Yet Recruiting |
| Monash Health | Clayton | Australia | Not Yet Recruiting |
| Austin Health | Melbourne | Australia | Not Yet Recruiting |
| Linear Clinical Research | Nedlands | Australia | Recruiting |
| Gold Coast Hospital | Southport | Australia | Not Yet Recruiting |
| Hopital Henri-Mondor | Créteil | France | Not Yet Recruiting |
| Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Claude Huriez | Lille | France | Not Yet Recruiting |
| Hôpital Lyon Sud | Lyon | France | Not Yet Recruiting |
| CHU Nantes - Hotel Dieu | Nantes | France | Not Yet Recruiting |
| Institut Gustave Roussy | Villejuif | France | Not Yet Recruiting |
| Centro di Riferimento Oncologico (CRO Aviano) | Aviano | Italy | Not Yet Recruiting |
| ASST Papa Giovanni XXIII | Bergamo | Italy | Not Yet Recruiting |
| University of Bologna | Bologna | Italy | Not Yet Recruiting |
| Istituto Clinico Humanitas | Rozzano | Italy | Not Yet Recruiting |
| Pratia Onkologia Katowice | Katowice | Poland | Not Yet Recruiting |
| Pratia MCM Krakow | Krakow | Poland | Not Yet Recruiting |
| Szpital AidPort | Skorzewo | Poland | Not Yet Recruiting |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warsaw | Poland | Not Yet Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Not Yet Recruiting |
| Hospital General San Pedro De Alcantara | Cáceres | Spain | Not Yet Recruiting |
| The START Center for Cancer Care - Madrid (Fundacion Jimenez Diaz) | Madrid | Spain | Not Yet Recruiting |
| START Madrid - Hospital Universitario Madrid Sanchinarro | Madrid | Spain | Not Yet Recruiting |
| Hospital Universitario Virgen del Rocio | Seville | Spain | Not Yet Recruiting |
On this site
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07691606 on ClinicalTrials.gov ↗ ← All trials in the USA