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Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03535246
Recruitment Status : Unknown
Verified September 2019 by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute.
Recruitment status was:  Recruiting
First Posted : May 24, 2018
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):
Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute

Brief Summary:
The primary objectives are to evaluate the safety and efficacy of infusion of autologous tumor associated antigen-specific engineered immune effector cells (EIE).

Condition or disease Intervention/treatment Phase
Cancer Biological: Engineered Immune Cells Phase 1 Phase 2

Detailed Description:

Malignant tumor is still a major challenge in medicine and requires technology breakthrough, and its mortality rate is the highest among all diseases. World Health Organization and the American Cancer Association expect about 12 million new cancer patients worldwide each year, with about 8 million cancer deaths (20 thousand cancer deaths per day). At present, more than 20 million people are suffering from cancer, and this figure will increase to 75 million in 2030. In Asia, the incidence of cancer is expected to rise by 60% in 2020, and the number of cancer related deaths will reach 7 million annually in 2030. The incidence of lung, Intestine, breast, prostate and gastric cancer is high, and lung, Intestine, breast and liver cancer are the main causes of cancer related deaths in Asia.

Adoptive immunotherapy based on cytotoxic T lymphocytes reactive with specific antigens has proven to be effective. In vitro induction of tumor antigen-specific immune cells and engineering of target specific immune cells have great potential for cancer eradication. The study aims to evaluate the safety and efficacy of ex vivo manipulated EIE cells including chimeric antigen receptor (CAR) modified immune cells in treating cancer. The primary study objectives are to evaluate the safety of the investigational product, autologous EIE cells, to subjects by intravenous and intratumoral injection. The secondary study objectives are (1) to evaluate the success rate of generating autologous EIE cells ex vivo, and (2) to determine the anti-cancer efficacy of the EIE cells.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tumor Associated Antigen-specific Engineered Immune Effector Cells (EIE) Against Cancer
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Arm Intervention/treatment
Experimental: Single arm
EIE cells to treat cancer.
Biological: Engineered Immune Cells
Engineered immune effector cells (EIE)

Primary Outcome Measures :
  1. percentage of adverse effects after EIE cell injection [ Time Frame: up to one month ]
    To assess the safety of autologous EIE cells in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.

Secondary Outcome Measures :
  1. Rate of successful EIE generation [ Time Frame: up to one month ]
    The percentage of successful EIE generation, which are derived from subjects and pass the safety test after standard culture procedures, viable for at least one preparation, will be evaluated.

  2. Ability of EIE cells to induce anti-cancer reaction [ Time Frame: after 1 month from EIE cells infusion until 12 months after infusion ]
    measurement of TAA concentration in blood sample

  3. Ability of EIE cells for anti-cancer reaction [ Time Frame: after 1 month from EIE cells infusion until 24 months after infusion ]
    Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 1. Written, informed consent obtained prior to any study-specific procedures. 2. The results of immune staining of the patient's cancer specimens positive for any one or more of tumor-associated antigens, such as GD2, mesothelin, P16, MMP, Melan A, MAGE A1, MAGE A3, and MAGE A4.

    3. Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2. 4. Life expectancy ≥ 3 months. 5. Able to comply with the protocol. 6. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV.

    7. Not pregnant, and on appropriate birth control if of childbearing potential.

    8. Adequate bone marrow reserve with

    • absolute neutrophil count (ANC) ≥ 1000/mm3.
    • Platelets ≥100,000/mm3. 9. Adequate renal and hepatic function with
    • Serum creatinine ≤ 2 x upper limit of normal (ULN).
    • Serum bilirubin ≤ 2 x ULN.
    • aspartate aminotransferase (AST)/ALT ≤ 2 x ULN.
    • Alkaline phosphatase ≤ 5 x ULN.
    • Serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.

Exclusion Criteria:

  • 1. The results of immune staining of the patient's tumor-associated antigens are all negative.

    2. Previous experience of other cell therapy. 3. Participation in any other cell therapy protocols within one year. 4. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug.

    5. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).

    6. Pregnant or lactating females. 7. Unable to comply with the trial related requirement. 8. Inadequate bone marrow function:

    • Absolute neutrophil count < 1.0 x 10e9/L.• Platelet count < 100 x 10e9/L.• Hb < 9 g/dL.

Inadequate liver and renal function:

  • Serum (total) bilirubin > 1.5 x ULN.
  • AST & ALT > 2.5 x ULN (> 5 x ULN in patients with liver metastases).
  • Alkaline phosphatase > 2.5 x ULN (or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases).
  • Serum creatinine >2.0 mg/dl (> 177 μmol/L).
  • Urine dipstick for protein uria should be < 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate < 1 g of protein/24 hr.

    9. Serious active infection requiring i.v. antibiotics at during screening. 10. Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03535246

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Contact: Lung-Ji Chang, PhD 86-075586725195
Contact: Yichun Cai, MD 86-13802830754

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China, Guangdong
QiFu Hospital of Guangzhou University of Chinese Medicine Recruiting
GuangZhou, Guangdong, China, 510415
Contact: Yichun Cai, MD    86-13802830754      
Shenzhen Geno-immune Medical Institute Recruiting
ShenZhen, Guangdong, China, 518000
Contact: Lung-Ji Chang, PhD    86-075586725195   
China, Yunnan
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center Recruiting
KunMing, Yunnan, China, 650000
Contact: Xun Lai, MS    13577096609   
Sponsors and Collaborators
Shenzhen Geno-Immune Medical Institute
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Responsible Party: Lung-Ji Chang, Principal Investigator, Shenzhen Geno-Immune Medical Institute Identifier: NCT03535246    
Other Study ID Numbers: GIMI-IRB-18001
First Posted: May 24, 2018    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lung-Ji Chang, Shenzhen Geno-Immune Medical Institute:
T cell
Gene therapy