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)
Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma
About this trial
This is an interventional treatment trial for Diffuse Large B-Cell Lymphoma focused on measuring Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma, Cancer, B-Cell Malignancies, ABBV-319
Eligibility Criteria
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.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- 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.
- Know active infection or clinically significant uncontrolled conditions as per the protocol.
Sites / Locations
- University of Arizona Cancer Center - Tucson /ID# 247752Recruiting
- Sylvester Comprehensive Cancer Center - University of Miami Hospital & Clinics /ID# 247232Recruiting
- Novant Health Presbyterian Medical Center /ID# 246719Recruiting
- Baylor Sammons Cancer Center /ID# 247715Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Dose Escalation ABBV-319
(ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants
(ABBV-319) Follicular Lymphoma (FL) Participants
(ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants
Participants with relapsed or refractory (R/R) B cell lymphomas including diffuse large b-cell lymphoma (DLBCL) or follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) will receive escalating doses of ABBV-319 in 21-day cycles, until the recommended Phase 2 dose (RP2D) is determined.
Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.
Participants with R/R FL will receive ABBV-319 in 21-day cycles.
Participants with R/R CLL will receive ABBV-319 in 21-day cycles.