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)

Study Identifier
M22-716
CT.gov Identifier
NCT05512390
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Blood Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
  • Blood Cancer - Chronic Lymphocytic Leukemia (CLL)
  • Blood Cancer - Follicular Lymphoma (FL)
    • Study Drug
  • ABBV-319
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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. * 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.

    Protocol 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.

    Study Locations

    Location
    Status
    Location
    University of Arizona Cancer Center - Tucson /ID# 247752
    Tucson, Arizona, United States, 85724
    Status
    Recruiting
    Location
    Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
    Miami, Florida, United States, 33136
    Status
    Completed
    Location
    Allina Health System /ID# 251782
    Minneapolis, Minnesota, United States, 55407-1321
    Status
    Recruiting
    Location
    University of Nebraska Medical Center /ID# 246715
    Omaha, Nebraska, United States, 68198
    Status
    Recruiting
    Location
    Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
    New York, New York, United States, 10065-6007
    Status
    Recruiting
    Location
    Novant Health Presbyterian Medical Center /ID# 246719
    Charlotte, North Carolina, United States, 28204
    Status
    Recruiting
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