Clinical trial · Interventional
A Study of ARC-02 in B-cell NHL
A Study to Evaluate Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity of ARC-02 in Adult Participants With B-cell Non-Hodgkins Lymphoma (NHL)
NCT07691606CI-TRIAL-00123969ABLATE-101recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Non Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ARC-02 | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part A Dose Escalation: ARC-02 Monotherapy
- description
- Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity.
- interventionNames
- Drug: ARC-02
- type
- EXPERIMENTAL
- label
- Part A Dose Expansion: ARC-02 Monotherapy
- description
- 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.
- interventionNames
- Drug: ARC-02
- type
- EXPERIMENTAL
- label
- Part B Dose Escalation: ARC-02 in Combination with Rituximab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.