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 : Completed
First Posted : January 20, 2017
Last Update Posted : August 28, 2019
|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)|
|Actual Enrollment :||6 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|
|Actual Primary Completion Date :||February 7, 2019|
|Actual Study Completion Date :||February 7, 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03027128
|United States, California|
|Chan Soon-Shiong Institute for Medicine|
|El Segundo, California, United States, 90245|