GT201 is a next-generation gene-edited TIL product independently developed by Grail Bio, expressing membrane-bound cytokines. In preclinical studies, the most optimized structural design was compared and selected, and stable expression was achieved on TIL cells from multiple batches and different tumor sources through the retroviral system StaViral?, which was custom-designed for engineered TIL therapy.

Now, this solid tumor breakthrough technologyFinally officially launched clinical trials!Patients in China can now access throughGlobal Cancer Doctors Network Medical Department (4006667998), understand the detailed inclusion and exclusion criteria, or preliminarily assess whether you qualify for participation.

Introduction to Anti-Cancer Projects

Suitable for which patients?

Applicable to patients with lung cancer or cervical cancer, requiring two lesions: one surgically resectable and the other for tumor evaluation.

Inclusion Criteria (Partial)

Subjects must meet all of the following criteria to be enrolled in this study:

1) Voluntarily join the study, sign the informed consent form, and be willing and able to comply with the study protocol.

2) Aged 18 to 70 years old (cases over 70 years old will be jointly decided by the investigator and the medical monitor of the collaborator).

3) Diagnosed as: Patients with advanced solid tumors who have failed standard treatment or are unable to receive standard treatment.

4) At least one lesion that has not received radiotherapy or other local treatments, from which tumor tissue can be obtained (preferably superficial lymph nodes), and from which a tissue block weighing ≥1.0g can be isolated (can be sourced from a single lesion or combined from multiple lesions) for the preparation of autologous tumor-infiltrating lymphocytes; minimally invasive procedures should be used as much as possible.

5) After tumor sampling, there is still at least one measurable lesion defined by the RECIST v1.1 criteria.

6) At the time of screening, patients with ≤3 untreated central nervous system metastases may be included.

7) Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

8) Expected survival time ≥ 12 weeks.

Exclusion Criteria (Partial)

Subjects must also exclude all the following criteria that make them unsuitable for participating in this clinical study before they can be enrolled:

1) Patients with spinal cord compression that has not been relieved by surgery and/or radiotherapy are not eligible for enrollment (Patients who have been treated and show clinical evidence of symptom relief 21 weeks prior to surgical sampling are eligible for enrollment).

2) Those with uncontrolled tumor-related pain as judged by the investigator. Subjects requiring analgesic drug treatment must have a stable analgesic treatment regimen at the time of entering the study; symptomatic lesions suitable for palliative radiotherapy should complete treatment before entering the study.

3) As assessed by the investigator, there is a risk of major bleeding: high bleeding risk (examples include, but are not limited to, tumors encircling or infiltrating major blood vessels [i.e., carotid artery, jugular vein, bronchial artery] and/or exhibiting other high-risk characteristics, such as fistulas, significant cavitary lesions, history of prior bleeding [≤60 days]).

4) Patients with interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory diseases that severely affect lung function.

5) Any active autoimmune disease, history of autoimmune disease, or condition requiring systemic corticosteroids or immunosuppressive drug therapy (>10 mg/day of prednisone or equivalent hormone) within 14 days prior to lymphocyte-clearing chemotherapy.

6) A history of cardiovascular disease with significant clinical implications, including but not limited to: ① congestive heart failure (NYHA class >2); ② unstable angina; ③ myocardial infarction occurred within the past 3 months; ④ any supraventricular or ventricular arrhythmia requiring treatment or intervention.

7) Arterial/venous thrombotic events that occurred within 6 months prior to enrollment, including but not limited to cerebrovascular accidents, deep vein thrombosis, and pulmonary embolism.

8) Bleeding events that occurred within 6 months prior to enrollment: including but not limited to gastrointestinal bleeding caused by fundic or esophageal varices, increased risk of bleeding due to portal hypertension, active gastrointestinal bleeding, and other similar conditions.

Clinical Benefit to Patients

1）Free medication: The study drug will be provided free of charge until disease progression.

2）Free Examination: Free relevant tests required for the trial after being informed.

3）Transportation Allowance: Traffic subsidies related to clinical research.

4）Regular Follow-up by Experts: Full-service expert team, institutions focus on patients' physical conditions in the long term.

Summary of Required Documents to Submit

The materials that patients need to prepare and submit include:Pathology Report, Gene Test Report, Admission Record, Discharge Summary, CT/MRI Examination, Complete Blood Count, Liver and Kidney Function, Coagulation Function, Infectious Disease Screening, Electrocardiogram Reportetc.

Global Oncology Department Kindly Reminder

If you would like to participate in this clinical study or learn more about TIL cell therapy, please contactGlobal Cancer Doctors Network Medical Department (400-666-7998), obtain more information about applications both in China and internationally, or apply directly. We commit to keeping all participants' personal information confidential and guarantee adherence to China's laws and regulations related to clinical research throughout the entire process.

This article is original from Global Cancer Doctors Network. Reproduction is strictly prohibited without authorization.

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