Solid Tumor Clinical Trial
Official title:
Open-label, Phase 1 Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors
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.
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.
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