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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-525606-35-00 | EU Trial (CTIS) Number |
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This study is to assess safety, tolerability, pharmacokinetics (PK), pharmacodynamic (PD), and preliminary efficacy of ARC-02.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Dose Escalation: ARC-02 Monotherapy | Experimental | Participants will receive ARC-02 at multiple dose levels on Day 1 of each cycle until disease progression or unacceptable toxicity. |
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| Part A Dose Expansion: ARC-02 Monotherapy | Experimental | 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. |
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| Part B Dose Escalation: ARC-02 in Combination with Rituximab | Experimental | 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. |
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| Part B Dose Expansion: ARC-02 in Combination with Rituximab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARC-02 | Drug | Intravenous (IV) infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: ORR as Assessed by the Investigator | Up to 5 years | |
| Dose Expansion: Number of Participants with TEAEs and SAEs | Up to 5 years | |
| Dose Escalation and Expansion: Time to Response (TTR) |
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Inclusion Criteria:
A documented diagnosis of B-cell Non- Hodgkin Lymphoma (NHL) per 2016 World Health Organization criteria and disease requiring treatment:
Measurable disease.
Received at least 2 prior lines of systemic therapies and not eligible to receive additional standard of care therapies.
An Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 at screening.
Adequate organ function within 3 days of the first dose of study intervention.
A negative blood pregnancy test within 7 days prior to first dose of study intervention (for women of childbearing potential).
Exclusion Criteria:
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.
Use of:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taiho Oncology, Inc. | Contact | +1 844-878-2446 | ABLATE-101@taihooncology.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Start Cala | Recruiting | Los Angeles | California | 90025 | United States | |
| Norton Cancer Institute |
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| Rituximab | Drug | IV infusion. |
|
| Up to 5 years |
| Dose Escalation and Expansion: Duration of Response (DOR) | Up to 5 years |
| Dose Escalation and Expansion: Progression-free Survival (PFS) | Up to 5 years |
| Dose Escalation and Expansion: Maximum Observed Plasma Concentration (Cmax) | This will be assessed for antibody conjugated monomethyl auristatin E (acMMAE), total anti-CD79b antibody and free monomethyl auristatin E (MMAE). | Up to 5 years |
| Dose Escalation and Expansion: Apparent Elimination Half-Life (t½) | This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE. | Up to 5 years |
| Dose Escalation and Expansion: AUC From Time 0 to Infinity (AUC0-inf) | This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE. | Up to 5 years |
| Dose Escalation and Expansion: AUC to the Last Measurable Concentration (AUC(0-τ) | This will be assessed for acMMAE, total anti-CD79b antibody and free MMAE. | Up to 5 years |
| Dose Escalation and Expansion: Number of Participants with Antidrug Antibodies (ADA) and Neutralizing Antibodies (Nab) | Up to 5 years |
| Not yet recruiting |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| NYU Langone | Not yet recruiting | New York | New York | 10016 | United States |
| Levine Cancer Institute | Not yet recruiting | Charlotte | North Carolina | 28204 | United States |
| Massey Cancer Center | Not yet recruiting | Richmond | Virginia | 23298 | United States |
| Summit Cancer Centers - North Spokane | Recruiting | Spokane | Washington | 99208 | United States |
| Froedtert & Medical College of Wisconsin | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
| Monash Health | Not yet recruiting | Clayton | 3168 | Australia |
| Austin Health | Not yet recruiting | Melbourne | 3084 | Australia |
| Linear Clinical Research | Not yet recruiting | Nedlands | 6009 | Australia |
| Gold Coast Hospital | Not yet recruiting | Southport | 4215 | Australia |
| Hopital Henri-Mondor | Not yet recruiting | Créteil | 94010 | France |
| Centre Hospitalier Universitaire de Lille (CHU Lille) - Hopital Claude Huriez | Not yet recruiting | Lille | 59037 | France |
| Hôpital Lyon Sud | Not yet recruiting | Lyon | 69495 | France |
| CHU Nantes - Hotel Dieu | Not yet recruiting | Nantes | 44000 | France |
| Institut Gustave Roussy | Not yet recruiting | Villejuif | 94805 | France |
| Centro di Riferimento Oncologico (CRO Aviano) | Not yet recruiting | Aviano | 33081 | Italy |
| ASST Papa Giovanni XXIII | Not yet recruiting | Bergamo | 24127 | Italy |
| University of Bologna | Not yet recruiting | Bologna | 40138 | Italy |
| Istituto Clinico Humanitas | Not yet recruiting | Rozzano | 20089 | Italy |
| Pratia Onkologia Katowice | Not yet recruiting | Katowice | 40-519 | Poland |
| Pratia MCM Krakow | Not yet recruiting | Krakow | 30-727 | Poland |
| Szpital AidPort | Not yet recruiting | Skorzewo | 60-185 | Poland |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Not yet recruiting | Warsaw | 02-781 | Poland |
| Hospital Universitari Vall d'Hebron | Not yet recruiting | Barcelona | 8035 | Spain |
| Hospital General San Pedro De Alcantara | Not yet recruiting | Cáceres | 10003 | Spain |
| The START Center for Cancer Care - Madrid (Fundacion Jimenez Diaz) | Not yet recruiting | Madrid | 28040 | Spain |
| START Madrid - Hospital Universitario Madrid Sanchinarro | Not yet recruiting | Madrid | 28050 | Spain |
| Hospital Universitario Virgen del Rocio | Not yet recruiting | Seville | 41013 | Spain |
| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008258 | Waldenstrom Macroglobulinemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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