A First-In-Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies
Lay Description
M22-716 is a Phase 1, FIH, open-label, dose escalation, dose expansion, biomarker/pharmacodynamic (PD) study of ABBV-319 in participants with relapsed or refractory (R/R) B-cell malignancies.
Category
- Cancers and Other Neoplasms
- Chronic Lymphoid Leukemia
- Lymphoma
- IRB Number
- STUDY00000167
- NCT Number
- NCT05512390
Eligibility
- Eligible Ages
- 18
- Eligible Genders
- All
- Accepts Healthy Volunteers
Inclusion Criteria
For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell malignancies including (but not limited to) the following, with histology based on criteria established by the World Health Organization (WHO) (Swerdlow et al 2016), and measurable disease requiring treatment: CLL/small lymphocytic lymphoma Mantle cell lymphoma Marginal zone lymphoma Waldenstrom macroglobulinemia (WM) DLBCL o Germinal center B-cell type o Activated B-cell type o Primary cutaneous DLBCL, leg type o Epstein-Barr virus–positive (EBV+) DLBCL, not otherwise specified o DLBCL associated with chronic inflammation o Human herpesvirus 8-positive (HHV8+) DLBCL, not otherwise specified o B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma o High-grade B-cell lymphoma, not otherwise specified o High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements o DLBCL arising from FL (transformed FL) FL Grades 1 to 3B Participants must be considered relapsed or refractory to, or intolerant of, at least 2 previous therapies known to provide a clinical benefit for their condition, and for whom there is no locally available therapy known to provide clinical benefit (eg, standard chemotherapy or autologous stem cell transplantation [ASCT]). Complion Document ID: 6768000 CONFIDENTIAL Protocol M22-716, Version 3.0 39 of 131 CLL and indolent NHL patients must meet relevant disease specific requirements for treatment (eg, International Workshop on Chronic Lymphocytic Leukemia [iwCLL], National Comprehensive Cancer Network [NCCN], Groupe d’Etude des Lymphomes Folliculaires [GELF]). Participants in additional enrollment cohorts (including at lower doses) must provide archival or fresh tumor biopsies. If archived tissue is not available, a fresh tumor biopsy is required, unless collecting a biopsy at screening would place participant at risk of harm, would require a technically complicated procedure based on tumor location, or could hinder participant's ability to participate in the study. 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. Screening archival or fresh biopsy is not required for CLL subtype. Tumor biopsy requirements may be modified by Sponsor during the study.
Exclusion Criteria
Study Design
Arm Groups
Study Contact
Frances Crawford
210-450-5037
crawfordf1@uthscsa.edu
Myrna Montenegro
210-450-5954
montenegro@uthscsa.edu
Kathleen Rodriguez
210-450-1365
rodriguezk3@uthscsa.edu
Benjamin Schleif
210-450-1366
schleifb@uthscsa.edu
Morgan Seekatz
210-450-1133
seekatz@uthscsa.edu
Jessica Villarreal
villarreal24@uthscsa.edu
Principal Investigator
Daruka Mahadevan