What is clinical trial NCT05512390 studying?

NCT05512390 is a Phase 1 clinical trial evaluating ABBV-319 for Diffuse Large B-Cell Lymphoma. The trial is sponsored by AbbVie and is currently recruiting.

What phase is the NCT05512390 clinical trial?

NCT05512390 is a Phase 1 clinical trial. Phase 3 trials are pivotal studies required before FDA approval, typically enrolling hundreds to thousands of participants to prove efficacy and safety.

Is NCT05512390 still recruiting participants?

The current enrollment status of NCT05512390 is: RECRUITING. The trial is actively enrolling — check ClinicalTrials.gov for eligibility criteria.

Who is the sponsor of clinical trial NCT05512390?

NCT05512390 is sponsored by AbbVie (ABBV). BiotechSign currently grades the sponsor a C (58/100) based on its composite pipeline strength and catalyst outlook.

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NCT05512390Phase 1RECRUITING

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 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

Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia Follicular Lymphoma

Interventions / Drugs

ABBV-319

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment154 participants

Primary Completion—

Lead SponsorAbbVie

Data Retrieved2026-04-11 02:51:51.324665+00:00

What This Trial Means for Biotech Investors

Trial Phase Context

Phase 1 trials primarily test safety and dosing in a small number of participants (typically 20–100). Results do not yet speak to efficacy. FDA approval is typically many years away from this stage.

Status & Expected Data

Currently recruiting: the trial is enrolling patients. A data readout is not expected until after enrollment closes and the follow-up period is complete.

Enrolled: 154 participants

Sponsor Catalyst Profile

AbbVie Inc (ABBV) is the sponsoring company for this trial. BiotechSign currently grades this company C (58/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.

ABBV Full Pipeline →All Companies →

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