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Pharmaceutical composition and application thereof

A composition and drug technology, applied in the field of tumor drug research, can solve the problems of no cancer treatment effect and poor pertinence

Active Publication Date: 2017-05-31
HENAN HUALONG BIOLOGICAL TECH +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this invention, the PD-1 antibody is administered alone or combined with other antibodies, which is not highly targeted, and there is no strong evidence to prove that it has a significant therapeutic effect on cancer

Method used

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  • Pharmaceutical composition and application thereof
  • Pharmaceutical composition and application thereof
  • Pharmaceutical composition and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Example 1: Preparation of non-specifically expanded and activated T cells

[0074] The method for preparing non-specifically expanded and activated T cells comprises the following steps:

[0075] (1) Take 50 mL of peripheral blood from the patient (anticoagulated with heparin sodium), divide it into two 50 mL centrifuge tubes at 800 g, and centrifuge at 4°C for 15 min;

[0076] (2) After centrifugation, extract the upper layer of plasma and store it in a 50mL centrifuge tube in a refrigerator at 4°C;

[0077] (3) Dilute the blood cells in the centrifuge tube with normal saline 1:1, slowly add to the upper layer of the lymphocyte cell separation medium, and centrifuge at 800g, 20°C for 17min;

[0078] (4) After centrifugation, extract mononuclear cells (buffy coat) into a 50mL centrifuge tube, add normal saline to wash, centrifuge at 300g, 4°C for 8min, and wash twice;

[0079] (5) After cell counting, the cells were sorted by CD4 and CD8 magnetic beads, and the obtain...

Embodiment 2

[0083] Example 2: Inhibitory effect of pharmaceutical composition on mouse model renal cancer cells

[0084] (1) The establishment of the mouse kidney cancer model uses a subcutaneous inhibition model to facilitate the observation of tumor growth. Take 25 normal 6-week-old nude mice, each weighing about 20g, and inject 0.2mL renal cancer cell suspension subcutaneously at the right side of each nude mouse, and 10 days after the inoculation grows a 2-3mm tumor , the mouse melanoma model was successfully established.

[0085] (2) Grouping and processing

[0086] After modeling, mice were randomly divided into 5 groups, 5 in each group, including PBS control group (intraperitoneal injection of sterilized PBS 1mL), PD-1 monoclonal antibody treatment group (intraperitoneal injection of 2 mg / kg), and non-specific amplification and activation of T Cell treatment group (Bifidobacteria 5.83×10 9 ), the pharmaceutical composition treatment group, and the next day after the inoculation...

Embodiment 3

[0091] Embodiment 3: clinical experiment

[0092] Male, 50 years old. In December 2012, he was diagnosed with clear cell carcinoma of the left kidney and metastases to the lung bone. After surgical resection of the left kidney cancer, bisphosphonates were used as maintenance therapy. In May 2013, he received γ-knife radiotherapy for brain metastases. 2013.9-2014.10, oral Sutent treatment due to lung tumor progression, and γ-knife radiotherapy and whole brain radiotherapy during and in 2013.11 due to new brain lesions. 2014.11-2015.5: Due to the progress of brain and lung metastases, the treatment was changed to everolimus, during which γ-knife stereotactic radiosurgery was performed in 2014.4.

[0093] 2015.6-2016.1: Due to the re-progression of brain and chest tumors, PD-1 antibody (keytruda) 2mg / kg was applied once every three weeks, a total of 8 times. Non-specific expansion of activated T cells 5.83×10 9 / time, a total of 11 times. The results are shown in Figure 2. Fi...

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Abstract

The invention relates to the field of researches of anti-tumor drugs, and in particular relates to a pharmaceutical composition and application thereof. The composition comprises a PD-I antibody and a nonspecific amplification activated T cell. The pharmaceutical composition provided by the invention comprises the PD-I antibody and the nonspecific amplification activated T cell which have a synergistic effect to obviously inhibit growth of renal carcinoma cells and kill the renal carcinoma cells. The pharmaceutical composition provided by the invention has an obvious effect on renal carcinoma. The composition evaluated by an RESIST standard reaches PR (partial remission) or is close to CR (complete remission), and the effective rate reaches 100%. Moreover, the composition is quite small in side effects and is free of level-3 or level-4 adverse effects.

Description

technical field [0001] The invention relates to the field of tumor drug research, in particular to a pharmaceutical composition and its application. Background technique [0002] Tumor is a new organism formed by the body under the action of various tumorigenic factors, and the cells of local tissues lose their normal regulation of their growth at the gene level, resulting in abnormal proliferation and differentiation. Once a new organism is formed, it does not stop growing due to the elimination of the cause. Its growth is not regulated by normal body physiology, but destroys normal tissues and organs. This is especially obvious in malignant tumors. Compared with benign tumors, malignant tumors grow faster and show invasive growth, are prone to bleeding, necrosis, ulcers, etc., and often have distant metastasis, resulting in emaciation, weakness, anemia, loss of appetite, fever, and severe organ damage. Impairment of function, etc., eventually lead to death of the patient....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/395A61P35/00C12N5/0783A61K35/17
CPCA61K39/4644A61K39/4611A61K39/39558C12N5/0636A61K2239/49A61K2239/38A61K2239/47A61K2300/00C07K16/2818A61K2039/545A61P35/00G01N33/57438G01N2500/00C12N2501/515C12N2533/52A61K39/395A61K49/0008
Inventor 高全立韦丹
Owner HENAN HUALONG BIOLOGICAL TECH
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