Phase I Trial of Universal Donor NK Cell Therapy in Combination With ALT803

Summary

Participation Requirements

Description

Primary Objective: To determine the maximum tolerated dose (MTD) of ex vivo expanded non-HLA matched donor NK cells in combination with ALT-803 Secondary Objectives: Describe safety profile / toxicity of combining ALT-803 with NK cell adoptive therapy. Determine antitumor activity of allogeneic NK c...

Primary Objective: To determine the maximum tolerated dose (MTD) of ex vivo expanded non-HLA matched donor NK cells in combination with ALT-803 Secondary Objectives: Describe safety profile / toxicity of combining ALT-803 with NK cell adoptive therapy. Determine antitumor activity of allogeneic NK cells with ALT-803 support. Determine if a lymphocyte depleting regimen is adequate for preventing early elimination of HLA-mismatched donor NK cells by host T-cells. Study Design: This is a phase I study with "3+3" design with three planned dose levels of NK cells and a fixed dose of ALT-803. Three patients will be enrolled sequentially to each dose level, starting with dose level 1. Patients will be segregated to either receive ALT803 as cytokine support after NK cell infusion (starting with same dose level as Level 1) or no cytokine administration. Patients in the arm receiving ALT803 will be either hematologic malignancy patients (Cohort A) or Colon/Soft tissue sarcoma patients (Cohort B). Absence of dose limiting toxicity (DLT) in the DLT assessment period of 28 days must be documented for all patients enrolled a cell dose without ALT803 before the next cohort of patients to receive cytokines at that dose level can be enrolled. Patients can also be enrolled in parallel to the next cell dose level without cytokines.

Tracking Information