NCT03027128

QUILT-3.028: Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors

Open-label, Phase 1 Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether haNK™ for Infusion is safe and effective in the treatment of metastatic or locally advanced solid tumors.

Detailed description

This is a phase 1 trial in subjects with metastatic or locally advanced solid tumors. The study will be conducted in two parts: part 1 will involve dose escalation using a 3 + 3 design, and part 2 will involve the expansion of the MTD or HTD to further evaluate the safety of haNK. In part 1, 3 to 6 subjects will be sequentially enrolled starting at dose cohort 1, and subjects will be assessed for DLTs. * Cohort 1: 2 x 10\^9 cells per infusion. * Cohort 2: 4 x 10\^9 cells per infusion. * If needed, subjects will be enrolled into a dose de-escalation cohort (cohort -1): 1 x 10\^9 cells per infusion. In part 2, dose expansion will occur when the MTD or HTD has been determined. An additional 4 subjects may be enrolled in part 2, for a total of up to 10 subjects at the MTD or HTD.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
BIOLOGICAL	haNK™ for Infusion	haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).

Timeline

• Start date: 2017-08-02
• Primary completion: 2019-05-06
• Completion: 2019-05-06
• First posted: 2017-01-20
• Last updated: 2024-11-20
• Results posted: 2024-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study