NCT02099539

QUILT-3.005: A Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma

A Phase I/II Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Altor BioScience · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase I/II, open-label, multi-center, competitive enrollment and dose escalation study of N-803 in patients with relapsed or refractory multiple myeloma.

Detailed description

The purpose of this study is to evaluate the safety, determine the Maximum Tolerated Dose (MTD) or the Minimum Efficacious Dose (MED) and characterize the immunogenicity and pharmacokinetic profile of N-803 in treated patients. The effect of N-803 on the peripheral absolute lymphocyte counts and white blood cell counts, the number and phenotype of peripheral blood T (total and subsets) and NK cells will be evaluated. The anti-tumor responses of N-803 will also be assessed in this trial.

Conditions

• Relapsed or Refractory Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	N-803	Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

Timeline

• Start date: 2014-10-06
• Primary completion: 2018-06-19
• Completion: 2018-06-19
• First posted: 2014-03-31
• Last updated: 2024-09-26
• Results posted: 2024-09-26

Locations

4 sites across 1 country: United States