NCT04524455

Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor ALL

A Phase 1b Open-label Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Administration of Blinatumomab in Combination With AMG 404 for the Treatment of Adults With Relapsed or Refractory B Cell Precursor Acute Lymphoblastic Leukemia (ALL)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this phase 1b study is to evaluate the safety and tolerability of blinatumomab and AMG 404 in combination in adults with R/R B-ALL and to estimate the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of AMG 404 when combined with continuous intravenous infusion (cIV) blinatumomab.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Blinatumomab	Blinatumomab will be administered as a continuous intravenous infusion (cIV).
DRUG	AMG 404	AMG 404 will be administered as an intravenous infusion (IV).
DRUG	Dexamethasone Premedication	Dexamethasone will be administered orally or intravenously prior to blinatumomab treatment, as needed.

Timeline

• Start date: 2020-10-02
• Primary completion: 2023-01-24
• Completion: 2023-01-24
• First posted: 2020-08-24
• Last updated: 2024-04-08
• Results posted: 2024-04-08

Locations

19 sites across 9 countries: United States, Australia, Austria, France, Germany, Italy, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study