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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)
NCT05512390 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG ABBV-319
Study Locations (20)
Seoul Teugbyeolsi
- Seoul National University Hospital /ID# 263945 — Seoul
- Asan Medical Center /ID# 263220 — Seoul
- Samsung Medical Center /ID# 263294 — Seoul
Texas
- Baylor Sammons Cancer Center /ID# 247715 — Dallas
- University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234 — San Antonio
Other
- Hadassah Medical Center-Hebrew University /ID# 254885 — Jerusalem
- Hospital Universitario Fundacion Jimenez Diaz /ID# 265198 — Madrid
Arizona
- University of Arizona Cancer Center - Tucson /ID# 247752 — Tucson
Florida
- Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232 — Miami
Minnesota
- Allina Health System /ID# 251782 — Minneapolis
Nebraska
- University of Nebraska Medical Center /ID# 246715 — Omaha
New York
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246 — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2023-04-26 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05512390
The ClinicalTrials.gov registry entry for NCT05512390 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 154 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AbbVie, which has 603 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 1 intervention — of which ABBV-319 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05512390 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Seoul Teugbyeolsi, Texas, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05512390 about?
NCT05512390 is a clinical study titled "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)". 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...
What is the current status of trial NCT05512390?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 154 participants. The study started on 2023-04-26. Estimated completion is 2027-02.
What conditions does trial NCT05512390 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Follicular Lymphoma, Diffuse Large B-Cell Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05512390?
The interventions under investigation include: ABBV-319 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05512390?
This trial is sponsored by AbbVie, which has 603 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05512390 being conducted?
This trial has 20 study locations across Arizona, Florida, Minnesota, Nebraska, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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