Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05512390 | 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) | PHASE1 | RECRUITING | 154 | — | — | Apr 26, 2023 | Feb 1, 2027 | Jan 16, 2026 | 20 | United States, Australia +4 |
A DLT is defined as any adverse event (AE) for which a clear alternative cause cannot be established (eg, attributed to the disease under study, another disease, or to a concomitant medication by the study investigators or medical monitor).
AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Maximum observed serum concentration of ABBV-319.
Time to Cmax of ABBV-319.
Terminal phase elimination half-life of ABBV-319.
Area under the serum concentration versus time curve (AUC) of ABBV-319.
Incidence and concentration of anti-drug antibodies.
| Arm | Type | Description |
|---|---|---|
| Dose Escalation ABBV-319 | EXPERIMENTAL | 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 doses of ABBV-319 that will be used in the next phase are determined. |
| (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants | EXPERIMENTAL | Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles. |
| (ABBV-319) Follicular Lymphoma (FL) Participants | EXPERIMENTAL | Participants with R/R FL will receive ABBV-319 in 21-day cycles. |
| (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants | EXPERIMENTAL | Participants with R/R CLL will receive ABBV-319 in 21-day cycles. |
| Name | Type | Description |
|---|---|---|
| ABBV-319 | DRUG | Intravenous (IV); Infusion |
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 rela...