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NCT05512390PHASE1Recruiting

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)

AbbVie

Start Date

4/26/2023

Completion Date

2/1/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Interventions

DRUG

ABBV-319

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Conditions

Diffuse Large B-Cell LymphomaChronic Lymphocytic LeukemiaFollicular Lymphoma

Locations

University of Arizona Cancer Center - Tucson /ID# 247752

Tucson, Arizona 85724

United States

Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232

Miami, Florida 33136

United States

Allina Health System /ID# 251782

Minneapolis, Minnesota 55407-1321

United States

University of Nebraska Medical Center /ID# 246715

Omaha, Nebraska 68198

United States

Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246

New York, New York 10065-6007

United States

Novant Health Presbyterian Medical Center /ID# 246719

Charlotte, North Carolina 28204

United States

Baylor Sammons Cancer Center /ID# 247715

Dallas, Texas 75246

United States

University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234

San Antonio, Texas 78229

United States

Concord Repatriation General Hospital /ID# 249240

Concord, New South Wales 2139

Australia

St Vincent's Hospital Melbourne /ID# 247624

Fitzroy Melbourne, Victoria 3065

Australia

One Clinical Research Pty Ltd /ID# 248392

Nedlands, Western Australia 6009

Australia

Cross Cancer Institute /ID# 246717

Edmonton, Alberta T6G 1Z2

Canada

University Health Network_Princess Margaret Cancer Centre /ID# 243936

Toronto, Ontario M5G 2M9

Canada

The Chaim Sheba Medical Center /ID# 254884

Ramat Gan, Tel Aviv 5265601

Israel

Hadassah Medical Center-Hebrew University /ID# 254885

Jerusalem, 91120

Israel

Seoul National University Hospital /ID# 263945

Seoul, Seoul Teugbyeolsi 03080

South Korea

Asan Medical Center /ID# 263220

Seoul, Seoul Teugbyeolsi 05505

South Korea

Samsung Medical Center /ID# 263294

Seoul, Seoul Teugbyeolsi 06351

South Korea

Hospital Universitario Marques de Valdecilla /ID# 262826

Santander, Cantabria 39008

Spain

Hospital Universitario Fundacion Jimenez Diaz /ID# 265198

Madrid, 28040

Spain