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1 The International Congress of BMT 2017 In conjunction with 22 nd Annual Congress of KSBMT COI disclosure Name of author : Kyoo-Hyung Lee I have no personal or financial interests to declare. I have no financial support from an industry source at the current presentation.
2 NK Cell Therapy NK cell biology NK cell therapy University of Ulsan Asan Medical Center Kyoo-Hyung Lee
3 Human NK Cells Flow cytometry of PB lymphocytes from healthy subject NK-DC interaction and NK cell target recognition There are 10x10 9 lymphocytes in the blood Estimated 2x10 9 NK cells in the blood (3.3x10 7 /kg) (within 1 month after allogeneic HCT.) NK cells reconstitute most rapidly after allogeneic HCT when compared to CD8+ or CD4+ lymphocytes
4 Killer immunoglobulin receptors Inhibitory KIR2DL1 (CD158a) group 2 HLA-C KIR2DL2 (CD158b) group 1 HLA-C KIR2DL3 (CD158b) group 1 HLA-C KIR2DL5 unknown KIR3DL1 HLA-Bw4 KIR3DL2 HLA-A3, -A11 KIR3DL7 unknown C-type lectin receptors Inhibitory CD94/NKG2A/B HLA-E Activating CD94/NKG2C HLA-E CD94/NKG2E/H unknown Non-MHC class I specific Activating NKG2D MIC A, MIC B, ULBP-1, -2, -3 NKp46 unknown NKp44 unknown NKp30 unknown Natural cytotoxicity receptors Activating KIR2DS1 group 2 HLA-C KIR2DS2 group 1 HLA-C KIR2DL4 HLA-G KIR2DS4 unknown KIR2DS5 unknown KIR3DS1 unknown NK cell receptors (Farag S S et al. Blood 2002)
5 Donor-patient NK cell alloreactivity determined by HLA- C and B4 typing (Ligand mismatch) Pt A A B B C C Dr Dr HLA- Bw4 HLA- Bw4 HLA- C gr HLA- C gr HLA- C gr1 HLA- C gr2 HLA- Bw4 NK allo pos neg 1 1 pos neg pos pos dnr pos pos neg pos 1 1 pos neg pos neg dnr neg pos 1 1 Ligand HLA-C group 1 (Ser77, Asn80) HLA-C group 2 (Asn77, Lys80) HLA- Bw Not found + + HLA-Bw4 HLA type of NK alloreactive donor + + HLA-C group HLA-C group 1 + HLA-C group 2 and/or HLA-Bw4 + HLA-C group 1 and/or HLA-Bw4 Receptor KIR2DL2/3 KIR2DL1 KIR3DL1 HLA-C Gr1 HLA-C Gr2 KIR2DL2/3 KIR2DL1 Inhibited without ligand Allo-HCT HLA-C Gr1 HLA-C Gr2 KIR2DL2/3 KIR2DL1 Not inhibited HLA-B4 KIR3DL1 HLA-B4 KIR3DL1 Leukemia Patient NK cell Leukemia Donor NK cell
6 CD45+ leukemic cells Donor NK alloreactivity against host No Yes No of transplant Donor displaying anti-recipient NK clones 1/58 34/34* Disease ALL AML Transplant outcomes Rejection Acute GVHD grade II 16% 14% 0%* 0%* Bcr-Abl PCR results Relapse at 5 years ALL AML 90% 75% 85% 0%* Results of T cell depleted haploidentical-family HCT Survival of mice A single infusion of alloreactive human NK cells eradicated CML blast crises in NOD/SCID mouse. (Ruggeri et al, Science 2002)
7 MS-HCT U-HCT MSD-HCT (Hsu KC et al, Blood 2005) MUD-HCT (Hsu KC et al, BBMT 2006)
8 Case Summarized data of KIR genotyping from normal transplantation donors in Asan-KRIBB study (n=51) Donor Family relation Age KIR Genotyping Result (allele specifity) 2DL 2DS 3DL AB 5A 5B *001/ 002 4* DS1 3DP 1*001/ 2DP1 002/00 1* 심승 mother 64 O O O O O O O O O O O O O O 2 김춘 sister 49 O O O O O O O O O O 3 김수 daugth er 27 O O O O O O O O O O 4 김진 sister 25 O O O O O O O O O O O O O 5 윤지 mother 47 O O O O O O O O O 6 강모 father 48 O O O O O O O O O 7 이순 sister 45 O O O O O O O O O 8 윤진 brother 55 O O O O O O O O O O O O O 9 김미 mother 60 O O O O O O O O O O O 10 송희 son 31 O O O O O O O O O 11 진준 father 56 O O O O O O O O O O 12 조민 mother 46 O O O O O O O O O O O O O 13 이현 mother 53 O O O O O O O O O O 14 정교 brother 32 O O O O O O O O O 49 현민 sister 31 O O O O O O O O O O O O O 50 신수 sister 28 O O O O O O O O O 51 정정 mother 64 O O O O O O O O O KIR gene frequency(%) Inhibitory Gene Frequency KIR2DL1 group 2 HLA-C (100%) KIR2DL2 group 1 HLA-C (12%) KIR2DL3 group 1 HLA-C (96%) KIR2DL5 unknown (6%-43%) KIR3DL1 HLA-Bw4 (98%) KIR3DL2 HLA-A3, -A11 (100%) KIR3DL7 unknown Activating Gene Frequency KIR2DS1 group 2 HLA-C (37%) KIR2DS2 group 1 HLA-C (12%) KIR2DS3 (18%) KIR2DL4 HLA-G (100%) KIR2DS4 unknown (39%-86%) KIR2DS5 unknown (24%) KIR3DS1 unknown (31%) KIR haplotype assignment At least one of KIR2DL5, 2DS1, 2DS2, 2DS3, 2DS5, or 3DS1 present > haplotype B/x Otherwise, haplotype A/A (Cooley S et al, Blood 2009) Activating KIR in KIR genotyping
9 KIR gene haplotype in MUD-HCT (Cooley S et al, Blood 2009)
10 1277 AML patients undergoing UD-HCT MUD-HCT (Venstrom JM et al. NEJM 2012)
11 SNP in inhibitory KIR, KIR2DL1 313 pediatric AML or ALL patients undergoing MS, UD, or haploidentical -HCT RR: homozygous for KIR2DL1-R 245 CC: homozygous for KIR2DL1-C 245 RC: heterozygous for KIR2DL1-R 245 /C 245 Donor inhibitory KIR2DL1 allele polymorphism in MSD, MUD, HFD HCT (Bari R et al. JCO 2013)
12 NKp30 isoforms in GIST (Delahaye NF, et al. Nature Med 2011)
13 NK cell activator!!! by LifeExtension For targeted seasonal protection, NK Cell Activator contains an enzymatically modified rice bran shown to be a potent immune modulator. NK Cell Activator supports the activity of natural killer (NK) cells crucial components of your immune system.0 30 vegetarian tablets Item# Retail Price: $45.00 Your Price: $33.75 SAVE 25%
14 Lirilumab (BMS ) Fully human monoclonal antibody designed to block the interaction between KIR2DL-1,-2,-3 inhibitory receptors and their ligands.
15 LAK cell TIL cell CAR-T cell CIK cell NK cell Generation IL-2 IL-2 IL-2, IL-7, or IL-15 / anti- CD3 beads / OKT3 IFN-gamma, IL-2, OKT3, anti-cd3 monoclonal ab IL-15, IL-21 Phenotype CD3 + >95% CD8 + ~85% CD56 + ~30% CD3 + CD56 + ~30% CD56 + ~90% CD3 + CD56 + ~1% CD3 + CD56 - ~0.3% Auto vs allo Auto Auto Auto Auto Allo GVHD when used in allogeneic setting Prob yes Prob yes Prob yes Prob yes No Cell number ~10x T cells ( transduced cells) ~1-10x10 10 ~1-5x10 10
16 Role of CART cell therapy in AML no replacement for allogeneic HCT!!! (Kenderian SS, et al, BBMT 2017)
17 NK cell therapeutics Donor source (allogeneic vs. autologous) Primary vs. chemotherapy-priming vs. post HCT NK cell acquisition by separation vs. ex vivo expansion Optimum dose? Is there MTD?
18 Patient A. Autologous NK cell therapy B. Primary adoptive NK cell therapy Patient tumor NK cells Donor NK cells C. Adoptive NK cell therapy based on HLA-mismatched HCT Patient tumor Donor Donor chimerism HCT Stem cells NK cells Alloreactivity against tumor without rejection from the host!!!
19 MU-HCT MS-HCT Haplo-HCT CB-HCT US IBMTR data: D Souza A et al, BBMT 2017 in press
20 Clinical studies of systemic NK cell therapeutics (N=57) as of June 2017 (Clinicaltrial.com) Study phase I 21 I-II 17 II 15 II with random control 4 Median patient number: 20 (range, 1-140)
21 Clinical studies of systemic NK cell therapeutics (N=57) as of June 2017 (Clinicaltrial.com) Dx AML 24 ALL 10 MDS 7 MM 6 NHL 2 Neuroblastoma 6 HCC 5 NK cell source Haplo donor 36 Haplo, KIR-mismatched 1 MS or MU donor 5 Autologous 9 CB derived 4 Deceased (Cadaveric) 1 Unclear 1 Sarcoma or melanoma 3 Breast ca 2 NSCLCa 2 GI malignancies 2
22 Clinical studies of systemic NK cell therapeutics (N=57) as of June 2017 (Clinicaltrial.com) Ex vivo treatment Separation only 20 Expansion 25 Expansion and gene modification unclear 9 3 HCT None 40 Haplo-HCT 6 Autologous HCT 5 Allo-HCT 3 CB-HCT 1 Unclear 2 Pre-NK conditioning Associated with HCT CTX / Fludara / IL-2 / cetuximab or rituximab or G-CSF or TBI or clofarabine None 6 Lenalidomide based 3 Cetuximab 1 Bortezomib 1 Decitabine 1 Trastuzumab + IL-2 1 Hu3F8 + IL-2 1 Other chemo 5
23 동종자연살해세포서울아산병원 한국생명공학연구원공동연구요약 임상환자연구제목연구기간식약처허가번호발표단계수 1 차 반일치가족골수이식후발생할수있는암 / 백혈병의재발이나착상부전을예방하기위한공여자자연살해세포의투여 - 제 1상임상연구 상 식품의약품안전청생물의약 품안전팀. 임상시험승인번 호 406 호 명 Bone Marrow Transplant 45: , 차 혈액암또는고형종양환자에서 HLA-반일치가족공여자조혈세포이식후진행 / 재발한기저악성질환의치료를위한공여자자연살해세포투여 - 제 1-2상임상연구 상 식품의약품안전청생물의약품정책과승인번호 명 (46명) Biol Blood Marrow Transplant 20: , 차 불응성급성백혈병에서반일치조혈세포이식후공여자유래자연살해세포투여 - 제1-2a상임상연구 a 상 식품의약품안전처접수번호 명 Biol Blood Marrow Transplant 22: , 2016 고위험급성골수성백혈병및골수이형성 4 차 증후군에서반일치조혈세포이식단독또는이식후동종유래공여자자연살해세포투여의유효성과안전성평가를위한 현재 2b 상 식품의약품안전처접수번호 명 ( 예정 ) 진행중 (44 명등록 ) 무작위비교임상연구
24 반일치가족골수이식후발생할수있는암 / 백혈병재발이나착상부전을예방하기위한공여자자연살해세포의투여 제 1 상연구 <2007 년식약청임상시험계획승인번호 406 호 >
25 혈액암또는고형종양환자에서 HLA- 반일치가족공여자조혈세포이식후진행 / 재발한기저악성질환의치료를위한공여자자연살해세포투여 제 1-2 상연구 < 식약청임상시험계획승인번호생물의약품정책과 - 80> Days Patient conditioning HCT DNKI MNC MNC MNC Donor leukapheresis G-CSF BBMT Journal 2013 IF: 3.940
26 Cumulative incidence Event-free survival Overall survival Cumulative incidence Median F/U: 31.5 months (range, ) B ANC 500/µl Study (n=41) Control (n=31) Platelets 20,000/µl Study (n=41) Control (n=31) C Acute GVHD, gr. 2-4 Study (n=41) Control (n=31) D Chronic GVHD, mod-severe Study (n=41) Control (n=31) TRM Control (n=31) Study (n=41) Days after HCT Months after HCT Months after HCT E F G Months after HCT Months after HCT Months after HCT Study refractory AML (n=29) Study refractory ALL/lymphoma (n=8) Control refractory AML (n=22) Control refractory ALL/lymphoma (n=9) Choi I and Lee K-H, Biol Blood Marrow Transplant (May 2014)
27 Activating NK Cell Ligands in Leukemia Leukemia Activating NK cell ligands Expression B-ALL MICA/B Negative ULBPs Mostly negative PVR and Nectin-2 Negative or low CD48 and NTBA Negative or low MDS MICA/B Positive in 30% of patients AML MICA/B Negative MICA/B Mostly positive PVR and Nectin-2 Positive ULBPs Negative or very low NCR ligands Negative or very low CML MICA/B Mostly positive B-CLL MICA Negative ULBP1, 2 and 4 Negative ULBP3 Low (Verheyden S et al, Leukemia 2007)
28 불응성급성백혈병에서반일치조혈세포이식후공여자유래자연살해세포투여 - 제 1-2a 상임상연구 < 식품의약품안전처접수번호 >
29
30
31 Other NK cell related variables, such as donor-patient ligand allo-reactivity, donor KIR typing (KIR2DS1 positivity, KIR3DS1 positivity, B/x vs A/A haplotype), and expressions of CD94, NKG2D, KIR2DL1, KIR2DL2/3, KIR3DL1, NKp46, NKp44 failed to predict CR or leukemia progression.
32 progression P=0.030 progression P=0.021 progression P=0.044 P=0.001 P=0.001
33 Cytokine release syndrome observed after early DNKI
34 B Body weight (Kg) DNKI s D6 D9 D (x10 8 /kg) onset of fever Total bilirubin (mg/dl) - - Creatinine (mg/dl) ANC (/ul) Truncated at Days after HCT UPN 1292: 28 yo Female with AML, recurrent then refractory Suppl Fig 1
35 <2015 년식약처임상시험계획승인번호 호 ; > 고위험급성골수성백혈병및골수이형성증후군에서반일치조혈세포이식단독또는이식후공 여자유래자연살해세포투여의유효성과안전성평가를위한무작위비교임상연구 무작위배정층화 불응성 AML 1차불응대재발후불응말초아세포 <5% 대 5% High-risk AML CR1 대상환자수 각군 48 명총 96 명 현재 40 명등록치료중 Intermediate -2/high-risk MDS
36 Summary 1. The role of NK cell biology in terms of donor selection in allogeneic HCT remains to be defined. 2. DNKI with or without HCT is safe. 3. MTD of DNKI remains to be defined. 4. DNKI more effective in AML than in Precursor B cell ALL. 5. Enhanced DNKI toxicity related to cytokine release was observed when given early after haploidentical HCT. 6. Enhanced anti-aml effect was observed with higher NKp30 expression of donor NK cells
37 Asan Medical Center Adult Allogeneic HCT Team Korea Research Institute of Bioscience and Biotechnology Team Kyoo-Hyung Lee, Je-Hwan Lee, Jung-Hee Lee, Han-Seung Park, Eun-Ji Choi Young-Shin Lee, Young-Ah Kang, Mijin Jeon, Miee Seol, Seunghyung Baek Inpyo Choi Suk-Ran Yoon Soo-Yeon Park Hanna Kim Sol-Ji Jung Korean Health Technology R&D Project, Ministry of Health and Welfare (A121934) R&D Convergence Program of National Research Council of Science & Technology (CRC KRIBB) GRL project, Ministry of Education, Science and Technology (FGM ) KRIBB Research Initiative Program (KGM )
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Patient number Sex Age Animal contact 1 F 36 No 2 F 31 Cat scratch Result of biopsy/aspiration cytology of lymph nodes Chronic granulomatous inflammation with caseation necrosis, compatible with tuberculous
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www.keit.re.kr 2011. 11 Technology Level Evaluation ABSTRACT The Technology Level Evaluation assesses the current level of industrial technological development in Korea and identifies areas that are underdeveloped
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제204회 당뇨 / 췌장이식 - 개인 맞춤 당뇨병 치료 - 췌장이식이란? : 인슐린 주사와 당뇨합병증 악화로부터의 해방 - 2014.8.20(수) 김재현 삼성서울병원 내분비대사내과 박재범 삼성서울병원 이식외과 김 재 현 내분비대사내과 교수(장기이식센터) 진료분야 : 갑상선질환, 당뇨병, 부신질환 학력 1995-02 서울대학교 의과대학 의학과 졸업 (의학사)
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A Spatial Location Analysis of the First Shops of Foodservice Franchise in Seoul Metropolitan City Younghee Lee* 1 1 (R) 0 16 1 15 64 1 Abstract The foodservice franchise is preferred by the founders who
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기혼 여성이 사이버대학에서 상담을 전공하면서 겪는 경험 방기연 (고려사이버대학교 상담심리학과 부교수) * 요 약 본 연구는 기혼 여성의 사이버대학 상담전공 학과 입학에서 졸업까지의 경험을 이해하는 것을 목적으로 한 다. 이를 위해 연구참여자 10명을 대상으로 심층면접을 하고, 합의적 질적 분석 방법으로 분석하였다. 입학 전 에 연구참여자들은 고등교육의 기회를
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Clinical Correlation of HER-2/neu Overexpression in Patients with Breast Cancer Sung Yong Kim, Tae Yoon Kim, Jae Jun Kim, Chang Ho Kim, Ok Pyung Song, Min Hyuk Lee, Eui Han Kim 1, and Moo Sik Cho Departments
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ECG & EP CASES Young-Keun On, MD, PhD Division of Cardiology, Department of Medicine Cardiac & Vascular Center, Samsung Medical Center Sungkyunkwan University School of Medicine, Seoul, Korea A case of
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대한비만학회 제5회 연수강좌 저칼로리 레시피를 활용한 저칼로리 식단 작성하기 김 우 정 강남세브란스병원 영양팀 비만인구는 전 세계적으로 급속히 증가되고 있으 며, 00년에는 005년 유병률의 배인 세계인구의 약 60% 정도가 과체중 또는 비만일 것으로 예측되기 도 한다. 00년 국민건강영양조사 결과에 따르면 우 리나라의 성인 비만 유병률은 998년 6. %에서