Led by the People's Hospital of Jiangsu Province, approved by the Health and Family Planning Commission of Jiangsu Province, the nation’s first "ACTL targeted anti-tumor cell immunotherapy combined with TKI for the treatment of advanced EGFR-sensitive mutation-positive lung adenocarcinoma", jointly launched by multiple hospitals, is open at random , A blank-controlled multi-center phase II clinical study, and the current patient data is good. Now this project continues to recruit patients!

The significance of this clinical trial
In recent years, targeted therapy has become an important part of the treatment of non-small cell lung cancer (NSCLC), among which epidermal growth factor receptor (EGFR) is currently a high-profile tumor treatment target. At present, small molecule targeted drugs are the first-line drugs for the treatment of non-small cell lung cancer with EGFR mutations and are well tolerated. However, these patients with curative effects on small-molecule targeted drugs have a median effective time of only 9-12 months. Eventually, the treatment failed due to drug resistance and the cancer recurred.

ACTL Targeted Anti-tumor Cellular Immune Technology (ACTL Technology) is an internationally leading precision treatment that combines oncology, molecular biology, and immunology, which can kill cancer cells in a targeted and specific manner. The safety of the technology has been fully confirmed, and a large number of clinical practices have proved that ACTL technology has a clear anti-tumor effect.

In the early clinical practice, in addition to preliminary verification of the effectiveness of ACTL technology to directly kill cancer cells, it was also found that ACTL technology can also reverse, block or delay tumor cell resistance to small molecule targeted drugs, making the majority of NSCLC patients benefit.

The participating units of this clinical trial
The ACTL targeted anti-lung cancer cell immunotherapy multicenter clinical trial is the first domestic multicenter phase II clinical efficacy trial approved by the Health and Family Planning Commission for the treatment of cancer with immune cells. It is led by Jiangsu Provincial People's Hospital and more than 30 Class-A hospitals Participate together. The registration number of the Jiangsu Provincial Health and Family Planning Commission is JB201501.

The Jiangsu Provincial Health and Family Planning Commission is the presiding department of this clinical trial, the Jiangsu Provincial People's Hospital is the undertaking unit, and Shenzhen Yishi Kangning Biotechnology Co., Ltd. is the guarantee unit.

Subject name
ACTL-targeted anti-tumor cell immunotherapy combined with TKI for the treatment of advanced EGFR sensitive mutation-positive non-small cell lung cancer is a randomized open, blank-controlled multicenter phase II clinical trial.

standard constrain
1. Newly treated advanced or recurrent lung adenocarcinoma (except brain metastases);
  a. EGFR sensitive mutation positive (EGFR exon 19 deletion or exon 21 L858R substitution mutation);
  b. Patients who have been treated with oral EGFR-TKI for 3 months and have not progressed;
  c. The tumor tissue is HLA-I antigen positive;
  d. Have not received other treatments (except postoperative adjuvant chemotherapy);
  e. At least one of the tumor-associated antigens related to histopathological examination is positive, including: carcinoembryonic antigen (CEA), keratin (CK19), Her-2/neu, MAGE-A3 antigen, survivin antigen (survivin), Prostate specific membrane antigen (PSMA), HLA-II ≥1 items are positive;
  f. Tumor assessment has 1 or more measurable lesions;
2. Age from 18 to 75 years old; gender is not limited;
3. ECOG score ≤ 2 points; able to go to the research hospital for monthly inspection and follow-up;
4. Peripheral blood white blood cells (WBC) ≥3.0×109/L, peripheral blood hemoglobin (Hb) ≥80g/L, peripheral blood red blood cells (RBC) ≥3.0×1012/L, peripheral blood platelets ≥1×1011/L;
5. The subject or legal guardian can understand and sign the informed consent form;
6. No serious autoimmune diseases or immunodeficiency diseases, and the immune function is basically normal;
7. No infectious diseases (syphilis, AIDS), hepatitis B, hepatitis C inactive period;

Exclusion criteria
1. Brain metastases;
2. Those who are allergic to biological products;
3. Patients with severe primary diseases of cardiovascular, liver and kidney, liver function (ALT, AST) exceeding the upper limit of normal by 2.5 times, BUN or Cr exceeding the normal range (as judged by the doctor to be clinically significant), liver metastasis exceeding 5 Times or more;
4. Merge other malignant tumors;
5. People with mental illness and mental or language impairment;
6. Pregnancy (women of childbearing age with a positive pregnancy test) or lactating women;

treatment cost
Free ACTL cell preparations will be provided to patients in the trial group in strict accordance with relevant national regulations on clinical trials;
The patients in the control group will be provided with 1-2 courses of free ACTL treatment according to the wishes of the patients after they leave the group normally or after the clinical trial is over;
Icotinib will receive a free medicine after taking 36,000 yuan.

contact details
Patients across the country can call the following telephone for more information. You can also send pathology reports, imaging reports of recent disease progression, detailed treatment history, and medical history to the following mailbox for case screening. The research assistant will promptly inform you whether you meet the requirements for entry.

Jiangsu Nanjing People's Hospital

You can bring all the medical history data (discharge summary, pathology report, recent CT film, etc.) to the Chief Physician Zhu Lingjun in the 16th floor of the outpatient clinic every Monday morning.
Contact number: 18551988816
Email: zhulingjun01@126.com
Shenzhen, Guangdong Shenzhen Yishi Kangning Biotechnology Co., Ltd.
Contact number: 0755-86680658 ext. 8067
17727837603
Email: zhang.wenli@immuclin.com

The recruitment of patients continues. If you have such a patient, please contact us.

Online registration: Click "Read the original text" at the end of the article or scan the QR code below to fill in the information. The staff will contact you within 3 working days!