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CART临床的相关的信息(经NCI核实的实验组)

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发表于 2015-2-2 15:40:17 | 显示全部楼层 |阅读模式 来自: 中国广东广州
本帖最后由 豆豆爸 于 2015-2-2 15:45 编辑

临床的主要内容:

treatment of chemotherapy refractory EGFR positive advanced solid tumors(CART-EGFR )

所有医院及联系方式:

Beijing General Hospital of PLA(解放军总医院)  
weidong han, Dr      Ph: 86-10-13651392893     Email: hanwdrsw@sina.com
Kaichao Feng, Dr       Ph: 86-10-13811421950      Email: timothyfkc@126.com

具体入组等相关信息:

Summary

RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory into patient autologous T cells may make the body build immune response to kill cancer cells.

PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in treating patients with EGFR positive advanced solid tumors, such as lung cancer, colorectal cancer and ovary cancer.

Further Study Information

PRIMARY OBJECTIVES:

I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-EGFR vector (referred to as CART-EGFR cells).

II. Determine duration of in vivo survival of CART-EGFR cells. RT-PCR (reverse transcription polymerase chain reaction) analysis of whole blood will be used to detect and quantify survival of CART-EGFR TCR zeta:CD137 and TCR (T-cell receptor) zeta cells over time.

SECONDARY OBJECTIVES:

I. For patients with detectable disease, measure anti-tumor response due to CART-EGFR cell infusions.

II. Estimate relative trafficking of CART-EGFR cells in tumor bed.

III. Determine if cellular or humoral host immunity develops against the murine anti-EGFR, and assess correlation with loss of detectable CART-EGFR (loss of engraftment).

IV. Determine the relative subsets of CART-EGFR T cells (Tcm, Tem, and Treg).

OUTLINE: Patients are assigned to 1 group according to order of enrollment.

Patients receive anti-EGFR-CAR (coupled with CD137 and CD3 zeta signalling domains)vector-transduced autologous T cells on days 0,1, and 2 in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed intensively for 6 months, every 3 months for 2 years, and annually thereafter for 13 years.

Estimate relative trafficking of CART-EGFR cells in peripheral blood.

Eligibility Criteria

Inclusion Criteria:

1. Chemotherapy refractory EGFR-positive non-small cell lung cancer, colorectal cancer with liver metastasis,and chemotherapy resistant or relapsed ovary cancer.

2. Relapsed patients after anti-EGFR using antibody or kinase inhibitor therapy.

3. Patients must be 18 years of age or older.

4. Patients must have an ECOG (Eastern Cooperative Oncology Group )performance status of 0-2.

5. Patients must have evidence of adequate bone marrow reserve, hepatic and renal function as evidenced by the following laboratory parameters:

Absolute neutrophil count greater than 1500/mm3. Platelet count greater than 100,000/mm3. Hemoglobin greater than 10g/dl (patients may receive transfusions to meet this parameter).

Total bilirubin < 1.5 times upper limits of normal. Serum creatinine less than or equal to 1.6 mg/ml or the creatinine clearance must be greater than 70 ml/min/1.73m(2).

6. Seronegative for HIV antibody.

7. Seronegative for active hepatitis B, and seronegative for hepatitis C antibody.

8. Patients must be willing to practice birth control during and for four months following treatment.NOTE:women of child-bearing age must have evidence of negative pregnancy test.

9. Patients must be willing to sign an informed consent.

Exclusion Criteria:

1. Patients with life expectancy less than 12 months will be excluded.

2. Patients with uncontrolled hypertension (> 160/95), unstable coronary disease evidenced by uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> New York Heart Association Class II), or myocardial infarction within 6 months of study will be excluded.

3. Patients with any of the following pulmonary function abnormalities will be excluded: FEV(forced expiratory volume), < 30% predicted; DLCO (diffusing capacity of lung for carbon monoxide) < 30% predicted (post-bronchodilator); Oxygen Saturation less than 90% on room air.

4. Patients with severe liver and kidney dysfunction or consciousness disorders will be excluded.

5. Pregnant and/or lactating women will be excluded.

6. Patients with active infections, including HIV, will be excluded, due to unknown effects of the vaccine on lymphoid precursors.

7. Patients with any type of primary immunodeficiencies will be excluded from the study.

8. Patients requiring corticosteroids (other than inhaled) will be excluded.

9. Patients with history of T cell tumors will be excluded.

10. Patients who are participating or participated any other clinical trials in latest 30 days will be excluded.
有爱,就有奇迹!
 楼主| 发表于 2015-2-2 15:56:06 | 显示全部楼层 来自: 中国广东广州
是TKI治疗跟免疫治疗的对比,算是对阿梁贴子的一个详细的补充
有爱,就有奇迹!
发表于 2015-2-4 21:39:37 | 显示全部楼层 来自: 美国
Very informative. Thanks a lot!

点评

ur welcome  发表于 2015-2-5 14:26
有爱,就有奇迹!
发表于 2015-2-5 20:59:00 | 显示全部楼层 来自: 美国
请问,豆豆爸,您在旧贴里提到的“改变体质的蒜头”的方,能否给提供个链接。在Google 和百度上都没有找到唉! 多谢了。
另外,我看到您家里因为有一人呼吸道感染患病而造成多人受传染,下次您可以用Tea Trea Oil ,稀释后在房间里喷雾,同时每个人用稀释的oil 漱口(半杯水里加5-6滴,每天数次),那样可以有很好的预防效果。
在淘宝网上能买到好的Tea Trea Oil。希望有帮助

点评

蒜头的做法,就是一粒,或者切片,用酱油,糖,醋等腌制就可以了,好好吃的,最好用独子蒜  发表于 2015-2-6 08:56
我家是因为支原体感染,小孩子传染给全家的,哈哈,这个问题不大,多运动,增强体质就没问题,这个东西没一两年改善不了  发表于 2015-2-6 08:54
有爱,就有奇迹!
发表于 2015-2-6 00:48:04 | 显示全部楼层 来自: 美国
漱口时要gargle several times.
有爱,就有奇迹!
发表于 2015-2-6 11:12:17 | 显示全部楼层 来自: 中国上海
有什么实际的作用吗
原来好像是针对白血病和淋巴瘤的
听说这两种效果都不错
肺癌没有尝试过的说
有爱,就有奇迹!
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