A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)

Официальное название

A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies

Обзор

B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the doses of ABBV-319 that will be used in the next phase and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 154 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-day cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.

Вмешательства

• Препарат ABBV-319
  Intravenous (IV); Infusion

Первичные конечные точки

• Number of Dose-Limiting Toxicities (DLT) [Срок оценки: Day 42]
• Number of Participants with Adverse Events (AE) [Срок оценки: Up to 30 Months]
• Maximum Observed Serum Concentration (Cmax) of ABBV-319 [Срок оценки: Up to 6 Months]
• Time to Cmax (Tmax) of ABBV-319 [Срок оценки: Up to 6 Months]
• Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 [Срок оценки: Up to 6 Months]
• Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319 [Срок оценки: Up to 6 Months]
• Antidrug Antibody (ADA) [Срок оценки: Up to 6 Months]

Вторичные конечные точки (5)

• Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria [Срок оценки: Up to 6 Months]
• Duration of Response (DOR) [Срок оценки: Up to 6 Months]
• Time to Response [Срок оценки: Up to 6 Months]
• Progression Free Survival (PFS) Time [Срок оценки: Up to 30 Months]
• Overall survival (OS) Time [Срок оценки: Up to 30 Months]

Критерии участия

Критерии включения

• For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell malignancies including those with histology based on criteria established by the World Health Organization (WHO), and measurable disease requiring treatment, as per the protocol.
• For the relapsed or refractory diffuse large b-cell lymphoma (DLBCL), follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) dose expansion cohorts (Part 2) only: Participants with documented diagnosis of one of the B-cell malignancies noted in the protocol with histology based on criteria established by the WHO, and measurable disease requiring treatment, as per the protocol.
• Laboratory values meeting the criteria noted in the protocol.
• For participants previously treated with a CD19-targeting therapy (eg, CD19 monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent CD19-targeting therapy must be collected.
• Participant must have measurable disease, as defined by the 2014 Lugano Classification.

Критерии исключения

• Known active central nervous system (CNS) disease, or primary CNS lymphoma.
• Known active infection or clinically significant uncontrolled conditions as per the protocol.
• Eastern Cooperative Oncology Group (ECOG) performance status >= 2.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 8 центров

• University of Arizona Cancer Center - Tucson /ID# 247752 — Tucson
• Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232 — Miami
• Allina Health System /ID# 251782 — Minneapolis
• University of Nebraska Medical Center /ID# 246715 — Omaha
• Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246 — New York
• Novant Health Presbyterian Medical Center /ID# 246719 — Charlotte
• Baylor Sammons Cancer Center /ID# 247715 — Dallas
• University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234 — San Antonio

Австралия · 3 центра

• Concord Repatriation General Hospital /ID# 249240 — Concord
• St Vincent's Hospital Melbourne /ID# 247624 — Fitzroy Melbourne
• One Clinical Research Pty Ltd /ID# 248392 — Nedlands

South Korea · 3 центра

• Seoul National University Hospital /ID# 263945 — Seoul
• Asan Medical Center /ID# 263220 — Seoul
• Samsung Medical Center /ID# 263294 — Seoul

Канада · 2 центра

• Cross Cancer Institute /ID# 246717 — Edmonton
• University Health Network_Princess Margaret Cancer Centre /ID# 243936 — Toronto

Израиль · 2 центра

• The Chaim Sheba Medical Center /ID# 254884 — Ramat Gan
• Hadassah Medical Center-Hebrew University /ID# 254885 — Jerusalem

Испания · 2 центра

• Hospital Universitario Marques de Valdecilla /ID# 262826 — Santander
• Hospital Universitario Fundacion Jimenez Diaz /ID# 265198 — Madrid

Идентификаторы

NCT: NCT05512390 · M22-716

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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