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A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
University of Arizona Cancer Center - Tucson /ID# 247752
Tucson, Arizona, United States
Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
Miami, Florida, United States
Allina Health System /ID# 251782
Minneapolis, Minnesota, United States
University of Nebraska Medical Center /ID# 246715
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
New York, New York, United States
Novant Health Presbyterian Medical Center /ID# 246719
Charlotte, North Carolina, United States
Baylor Sammons Cancer Center /ID# 247715
Dallas, Texas, United States
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
San Antonio, Texas, United States
Concord Repatriation General Hospital /ID# 249240
Concord, New South Wales, Australia
St Vincent's Hospital Melbourne /ID# 247624
Fitzroy Melbourne, Victoria, Australia
Start Date
April 26, 2023
Primary Completion Date
February 1, 2027
Completion Date
February 1, 2027
Last Updated
January 16, 2026
154
ESTIMATED participants
ABBV-319
DRUG
Lead Sponsor
AbbVie
NCT05139017
NCT06337318
Data Source & Attribution
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