QUILT-3.028: Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors
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|ClinicalTrials.gov Identifier: NCT03027128|
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : January 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Biological: haNK™ for Infusion||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Phase 1 Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors|
|Actual Study Start Date :||August 2, 2017|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: haNK™ for Infusion
NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous Infusion
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).
Other Name: NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous
- Determination of maximum tolerated dose (MTD) or highest tested dose (HTD). [ Time Frame: 2 years ]
- Occurrence of dose-limiting toxicities (DLTs). [ Time Frame: 2 years ]
- Occurrence of treatment-emergent adverse event (AEs) and serious adverse events (SAEs). [ Time Frame: 2 years ]
- Objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 and immune-related response criteria (irRC). [ Time Frame: 2 years ]ORR is defined as the proportion of patients with a confirmed complete or partial response.
- Progression free survival (PFS) by RECIST and irRC. [ Time Frame: 2 years ]
- Overall survival (OS). [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027128
|Contact: Jim Farmer||310-853-7522||Jim.Farmer@NantKwest.com|
|United States, California|
|Chan Soon-Shiong Institute for Medicine||Recruiting|
|El Segundo, California, United States, 90245|