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Safety and Efficacy of Allogeneic Natural Killer Cells in Combination with Pembrolizumab in Patients with Chemotherapy-Refractory Biliary Tract Cancer: A Multicenter Open-Label Phase 1/2a Trial

 Galam Leem  ;  Sung-Ill Jang  ;  Jae-Hee Cho  ;  Jung Hyun Jo  ;  Hee Seung Lee  ;  Moon Jae Chung  ;  Jeong Youp Park  ;  Seungmin Bang  ;  Da-Kyung Yoo  ;  Hyo-Cheon Cheon  ;  Jae-Eun Kim  ;  Kyeong-Pill Lim  ;  In-Hye Jung  ;  Jung-Min Im  ;  Yong-Yoon Chung  ;  Seung Woo Park 
 CANCERS, Vol.14(17) : 4229, 2022-08 
Journal Title
Issue Date
allogeneic natural killer cell therapy ; chemotherapy-refractory advanced biliary tract cancer ; immunotherapy ; pembrolizumab
Background and aim: This study investigated the administration of combination therapy, allogeneic natural killer (NK) cells and pembrolizumab in the treatment of advanced biliary tract cancer to determine the safety and tolerability (phase 1) and the efficacy and safety (phase 2a).

Methods: Forty patients (phase 1, n = 6; phase 2a, n = 34) were enrolled between December 2019 and June 2021. The patients received highly activated allogeneic NK cells ("SMT-NK") on weeks 1 and 2 and pembrolizumab on week 1. This 3-week schedule (one cycle) was repeated until confirmed disease progression, intolerable adverse events (AEs), patient withdrawal, or finishing the maximum treatment schedule. The tumor response was evaluated after every three cycles.

Results: In phase 1, four patients (66.7%) experienced seven AEs, but no severe AE was observed. In phase 2a, 126 AEs occurred in 29 patients (85.3%). Severe AEs (≥grade 3) were reported in 16 patients (47.1%). The overall response rate (ORR) was 17.4% in the full analysis set and 50.0% in the per-protocol set.

Conclusions: SMT-NKs plus pembrolizumab resulted in no severe AEs directly related to the drug combination. The combination therapy also exerted antitumor activity with improved efficacy compared to the recent monotherapy with pembrolizumab in patients with advanced biliary tract cancer.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Park, Seung Woo(박승우) ORCID logo https://orcid.org/0000-0001-8230-964X
Park, Jeong Youp(박정엽) ORCID logo https://orcid.org/0000-0003-0110-8606
Bang, Seungmin(방승민) ORCID logo https://orcid.org/0000-0001-5209-8351
Lee, Hee Seung(이희승) ORCID logo https://orcid.org/0000-0002-2825-3160
Leem, Ga Lam(임가람) ORCID logo https://orcid.org/0000-0001-6490-0911
Jang, Sung Ill(장성일) ORCID logo https://orcid.org/0000-0003-4937-6167
Chung, Moon Jae(정문재) ORCID logo https://orcid.org/0000-0002-5920-8549
Cho, Jae Hee(조재희) ORCID logo https://orcid.org/0000-0003-4174-0091
Jo, Jung Hyun(조중현) ORCID logo https://orcid.org/0000-0002-2641-8873
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