NCT01874288

A Study of De-immunized DI-Leu16-IL2 Administered Subcutaneously in Participants With B-cell NHL

A Phase I/II Study of De-immunized DI-Leu16-IL2 Immunocytokine Administered Subcutaneously in Patients With B-cell Non-Hodgkin Lymphoma (NHL)

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Alopexx Oncology, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This dose-escalation study is designed for determining the safety, tolerability, pharmacokinetics (PK), biological, and clinical activity of DI-Leu16-IL2 administered to participants with cluster of differentiation 20 (CD20) positive NHL that have failed standard rituximab-containing therapy.

Detailed description

The participants will be enrolled during dose escalation and during 2 expansion cohorts of up to 12 participants each. The dose escalation portion of the trial will incorporate a modified accelerated titration design. Therefore, the trial will enroll 3 participants per dose level with a doubling of the dose at each level during the accelerated stage of the study (skipping every other dose level). Once the first instance of any Grade 3 or higher treatment related toxicity (with some notable exceptions) is observed on the first cycle, the accelerated stage will end and the trial will revert to a conventional design using cohorts of 3 or 6 participants (standard 3+3 design), with single step 2 milligrams (mg)/square meter (m\^2) increments. To further explore the clinical efficacy, additional participants (up to 12 per cohort) may be enrolled at the optimal biologic dose (OBD) or maximum tolerated dose (MTD). At the end of the study, participants may be enrolled into an open-label extension study (AO-101-EXT \[NCT02151903\]), at the discretion of the investigator.

Conditions

• B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	DI-Leu16-IL2	DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.

Timeline

• Start date: 2013-11-25
• Primary completion: 2014-01-27
• Completion: 2016-11-16
• First posted: 2013-06-11
• Last updated: 2020-11-24
• Results posted: 2020-11-24

Locations

5 sites across 1 country: United States