Spots Global Cancer Trial Database for QUILT-3.028: Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors

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Trial Identification

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

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

Study ID: NCT03027128

Conditions

Solid Tumor

Interventions

haNK™ for Infusion

Study Description

Brief 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.