Monocentric, phase I study for advanced sarcoma with adoptive immunotherapy with Cytokine-Induced Killer (CIK).
In the first part of the study Patient's' peripheral blood will be collected and CIK cell expansion and storage will occur at the Regina Margherita Children's Hospital Cell Factory.
In the second part of the study the Maximum Tolerated Dose (MTD) will be determined in order to find the Recommended Dose for Phase II (RP2D)

Start Date11 Jan 2021

Sponsor / Collaborator

Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant Anna

NCT03782363 / WithdrawnPhase 1IIT

A Phase I Study of Adoptive Immunotherapy With Cytokine-Induced Killer Cells in Relapsed and Non-resectable Sarcomas After Multimodal Treatment.

Start Date18 Dec 2020

Sponsor / Collaborator

Italian Sarcoma Group

[+1]

ChiCTR1900022309 / SuspendedEarly Phase 1IIT

A Randomized Controlled Study for Autologous DC-CIK Sequential Combined With Entecavir in the Treatment of Chronic Hepatitis B Virus

Start Date01 Sep 2019

Sponsor / Collaborator-

100 Clinical Results associated with Cytokine induced killer cell(Italian Sarcoma Group)

100 Translational Medicine associated with Cytokine induced killer cell(Italian Sarcoma Group)

100 Patents (Medical) associated with Cytokine induced killer cell(Italian Sarcoma Group)

Literatures (Medical) associated with Cytokine induced killer cell(Italian Sarcoma Group)

08 Sep 2021·Journal of Healthcare EngineeringQ4 · MEDICINE

Efficacy of Enhanced Cytokine-Induced Killer Cells as an Adjuvant Immunotherapy for Renal Cell Carcinoma: Preclinical and Clinical Studies

Q4 · MEDICINE

ArticleOA

Author: Zhao, Yi-Yi ; Wang, Run-Qing ; Meng, Ming-Yao ; Zhong, Yi-Ming ; Yang, Yang ; Hou, Zong-Liu ; Yang, Li-Rong ; Li, Lin

Cytokine-induced killer (CIK) cells have been proved to be an effective method of tumor immunotherapy in numerous preclinical and clinical studies. In our previous study, a new method was developed to prime and propagate CIK cells by the combination of IL-2 and IL-15, and this kind of CIK cells had enhanced antitumor effect on lung cancer. For renal cell carcinoma (RCC), immunotherapy plays an important role because of the poor efficacy of radiotherapy and chemotherapy. In this study, we further evaluated the antitumor effects of these enhanced CIK cells against RCC. Enhanced CIK cells were generated by IL-2 combined with IL-15 and identified by flow cytometry. HEK-293 and ACHN cell lines were used to verify the efficiency of CIK cells in vitro, and then the ACHN tumor xenograft model was also employed for in vivo study. In addition, the secreted cytokines including IFN-γ, granzyme B, TNF-α, and perforin, as well as the local microstructure were also studied. Subsequently, 20 patients with RCC were enrolled into our study, and 11 patients were randomly divided into the autologous CIK treatment group for clinical research. The results showed that enhanced CIK cells exert better antitumor effects in RCC in vitro (

p < 0.01

in HEK-293 and

p < 0.05

in ACHN）and in vivo (

p < 0.05

). Patients benefit overall survival from enhanced CIK therapy in our clinical study. Our present preclinical and clinical studies for the first time elucidated that these enhanced CIK cells would be used as an effective adjuvant therapy in the treatment of RCC.

01 Jun 2019·Zhongguo shi yan xue ye xue za zhi

[Efficacy of Autologous DC-CIK Cells Combined with Other Immune Cells in the Treatment of Hematological Malignancies -Retrospective Study].

Article

Author: Li, Xi-Ran ; Zhang, Mei ; Liu, Hai-Bo ; Ma, Tian-Tian ; Liu, Hua-Sheng ; Shi, Jing

OBJECTIVETo investigate the safety and clinical efficacy of autologous DC-CIK cells combined with other immune cells for patients with hematological malignancies and analyze patient prognosis.METHODS50 patients with hematological malignancies who received cellular immunotherapy from September 2014 to April 2016 were retrospectively studied in the First Affiliated Hospital of Xi'an Jiaotong University, 115 cases times of cellular immunotherapy were performed. According to the selected treatment, the patients were divided into the dual cell group (DC-CIK cell treatment) and the multi-cell group (DC-CIK cell combined with other immune cells); According to the treatment course, the patients were divided into the single course group (completed by ＜3 times) and the multiple course group. The changes of T lymphocyte subsets, blood routine indicators and KPS scores as well as the overall survival time before and after treatment were compared and analyzed.RESULTS[WTB1]The difference of general conditions before treatment including the number of patients, sex, age, T lymphocyte subsets, blood routine indicators, KPS scores and so on in 2 groups divided according to 2 kinds of treatment methods were not statistically significant, indicating that the 2 groups were comparable. Grouped by selected treatment, the CD4⁺/CD8⁺ ratio, Hb and Plt levels decreased in the dual cell group, compared with those before treatment(P＜0.05). The CD3⁺CD4⁺ ratio after treatment in multiple cell group decreased, compared with that before treatment (P＜0.05). The 3-year survival rate of patients in dual cell and multiple cell groups was 61.3% vs 69.8%, the overall survival time of patients in 2 groups was 32.4 months vs 39.6 months, there were no statisticall differences between 2 groups(P>0.05). Grouped by treatment course, the CD3⁺ ratio after treatment increased, while the Hb level after treatment decreased in single course group, compared with level before treatment(P＜0.05). The CD3⁺CD4⁺ ratio, Plt level decreased, while the KPS scores increased after treatment in multiple course group, compared with those before treatment(P＜0.05). The 3-year survival rate in single course and multiple course groups was 52% vs 76.4%, the overall survival time was 28.7 months vs 40.9 months respectively, statistically significant with difference (P＜0.05).CONCLUSIONAutologous DC-CIK cells combined with other immune cells in the treatment of hematological malignancies can change the immune function of the patients and improve the antitumor activity. The multi-course treatment can improve the quality of life, prolong the overall survival time, thus worthing clinical promotion.

01 Apr 2019·Pathology & Oncology ResearchQ4 · MEDICINE

Combined Treatment with Autologous CIK Cells, Radiotherapy and Chemotherapy in Advanced Cervical Cancer

Q4 · MEDICINE

Article

Author: Liu, Zong-Lan ; Tian, Yong-Wei ; Meng, Dan-Dan ; Xu, Zhi-Qiao ; Gao, Ling ; Li, Ning ; Xu, Yue ; Shen, Wen-Jie

To investigate the clinical efficacy of autologous cytokine induced killer (CIK) cells transfusion combined with radiochemotherapy in the treatment of advanced cervical cancer. A total of 89 hospitalized patients with advanced cervical cancer were admitted and divided into the treatment group (44 cases, autologous CIK cells transfusion combined with radiochemotherapy) and the control group (45 cases, radiochemotherapy) by a randomized non-blind method. Comparisons of therapeutic efficacies, immune functions, life qualities and survival rates were analyzed between the two groups. The short-term therapeutic efficacy of the treatment group was significantly higher than that of the control group. There was no significant difference in 1, 2 and 3 year survival rates between the two groups. Compared with pre-treatment, levels of CD3⁺, CD4⁺/CD8⁺ in peripheral blood were increased in the CIK group, which were reduced in the control group. In the CIK group,only the feeling was depressed on the 25th day post-treatment (T25) compared with the day before treatment (B1). However in the control group, the function of body, role, social and holistic health was obvious disordered on day T25 compared with day B1. On day T25, there were significant differences in function of body, social and holistic health between two groups. Autologous CIK cells transfusion combined with radiochemotherapy shows better short-term efficacy than radiochemotherapy alone in the treatment of advanced cervical cancer, which obviously improves immune function and life quality of patients with low side effects.

100 Deals associated with Cytokine induced killer cell(Italian Sarcoma Group)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Sarcoma	Phase 1	IT	Azienda Ospedaliera Ospedale Infantile Regina Margherita Sant Anna	18 Dec 2020
Sarcoma	Phase 1	IT	Italian Sarcoma Group	18 Dec 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


QUILT-3.039/3.060/3.070/3.080 (ASCO2020)	Not Applicable	Pancreatic Cancer	12	Chemoradiation + cytokine-induced NK and T cell activation + checkpoint inhibition + allogeneic haNK cells	(pnpebwcuim) = 50% mohhahbcrx (vqgxpnzoja ) View more	Positive	25 May 2020
ASCO2012	Not Applicable	Lung Cancer	-	Autologous cytokine-induced killer (Autologous CIK and DC)	(wbhbnnhrol) = uzsnvgjokp zmslzricdn (mbmuecxjgv )	Positive	20 May 2012

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