Gene and Cell Based Immunotherapy – Adoptive Cell Therapy

Adoptive cell therapy is an individualized therapy based on patient’s own immune cells to attack the specific cancer.

Chimeric Antigen Receptors T cell (CAR-T): CAR-T cell therapy uses specially altered T cells to fight cancer. Patient's T cells are collected from the blood through apheresis machine, and modified to produce special antibody structures called chimeric antigen receptors (CARs) on the T cell surface. These engineered CAR-Ts can target a specific antigen on the surface of the cancer cells, allowing the CAR-T cells to kill cancer cells.

Engineered Immune Effectors (EIEs): Engineered Immune Effectors are T cells which are expanded in culture using cancer antigen-presenting dendritic cells (DCs) which are specific to certain cancer types. These EIE T cells are based on the normal T Cell Receptor (TCR). The expanded cancer-targeting T cells (EIEs) are administered back to the patient.

Dendritic Cells (DCs): Dendritic cells are patient’s own antigen-presenting cells crucial in activating the specific immune reactions. When prepared against cancer-associated antigens, the role of the DC is to train immune cells, especially T cells, to target and kill cancer cells and establish cancer specific memory immunity.

Neoantigens or Neoepitopes: Neoantigens (Neoepitopes) are peptide-based cancer specific antigens generated through analysis of the mutations particular to a specific cancer cell by using advanced sequencing technology to discover the difference between the DNA of a tumor and a normal cell. This is a new strategy in cancer immunotherapy.  Because neoantigens target only the specific tumor, they tend to have less non-specific side effect.  Neoantigens are used in EIE and DC therapies.

Choosing the Right Adoptive Cell Therapy

Selecting the right therapy is based on individual cases. Generally, patients with a compromised immune system as a result of cancer or chemotherapy will benefit more from CAR-T and EIE and less from DC, as the latter will require a healthy immune system. Both CAR-T and EIE technologies are based on expansion of the patient’s T cells in culture, and then infuse them back to the patient.

Patients with an intact immune system can benefit from all therapies, with DC being the easiest and quickest treatment with little side effects.

The choice of immune cell treatment is also based on test results, and the best options may depend on the type of target antigens and individual patient’s condition.

Testing for Adoptive Cell Therapy

In order to design the best cell therapy against the patient’s specific tumor, individual tumor antigen profile must first be tested, unless the target antigens are well known specific type of cancer antigens.

IHC Staining: Immunohistochemistry (IHC) staining can be used for screening target antigens in CAR-T, EIE, or DC therapies. IHC can be done in our institute (GIMI).

Neoantigen Sequencing Analysis: To discover new tumor mutations based target antigens, patient’s tumor surgical specimen and normal blood cells will be collected for gene sequencing and molecular analysis in companies in collaboration with GIMI.

Immune Cell Preparation

CAR-T therapy – 1 week of preparation time.

EIE therapy – 20 days of preparation time.

DC therapy – 3-5 days of preparation time.

All types of Adoptive Cell Therapy will require an initial blood cell collection, called apheresis. This can be done in half a day. The patient can stay in the hospital during this preparation time, or can return home and come back when the cells are ready to be administered.

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PATIENT CONSULTATION AND TREATMENT PROCESS

Patients in China:

1 Patients normally get in contact with us by different means:

- The Shenzhen Geno-Immune Medical Institute official website.

- Past patients’ or doctors’ recommendations.

- Telephone contact: (GIMI) Tel: 86-0755-86573763.

- WeChat contact: via WeChat ID 深圳市免疫基因治疗研究院

2 After the initial contact, we will ask the patient to fill out a questionnaire and send us their complete medical records. The records should include the main pathology report and treatment history, the procedures or medications that have been performed, and the most recent imaging examination (CT, PET, MRI etc.), and the original medical documents obtained from the hospital (if applicable). Specially, please, indicate whether prior immunotherapies have been performed.

3 After receiving your information, our staff will review the information and submit it to our scientific experts for evaluation.

4 Once the patient and our team arrive at an agreement, we will proceed to the screening preparation. The patient will provide tumor section slides (about 20 pieces) or biopsy paraffin block, or bone marrow samples for target antigen screening (with a corresponding staining fee). A treatment plan will be proposed based on the staining results (tumor profile).

5 According to the patient's condition, the medical expert will recommend hospital associated with the specific clinical trial to enroll the patient for treatment, with an estimated total cost. The patient will sign a volunteer enrollment and technical service agreement forms and submit the IDs of patient/families for an invitation.

6 Patients can choose to do the blood cell  collection in Beijing or Shenzhen, or the specified hospital location. The institute will begin preparing therapeutic cells after receiving the cells.

7 For CART and EIE treatments, patients need to be pretreated in the hospital, called immune conditioning chemotherapy, before  T cell infusion. The staff of GIMI will follow up with the clinical process regularly after cell collection and infusion.

International patients:

1 Patients can obtain information about the Institute through different channels: (1) the official website of The Shenzhen Geno-immune Medical Institute, (2) the International Clinical Trial Registration Website, (3) recommendations from former patients or collaborating doctors;

2 If there is a domestic contact, it can be carried out according to the domestic patient consultation process.

3 If there is no domestic intermediate contact, the patient can contact the expert group by email (c@szgimi.org) or online contact to submit their medical records. The required documents include the medical history and pathology report, including disease and treatment history. The original medical history documents (if applicable) should be prepared in English or Chinese. Our scientific team will review the documents and conduct a comprehensive evaluation, after which the patient will be contacted to proceed with follow-up consultation.

4 The Institute will help recommend the hospital that carries out the specific treatment according to the disease review and evaluation.