Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT05430360
Eligibility Criteria:
Inclusion Criteria:
1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol
2. At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes
3. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
Exclusion Criteria:
1. Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment
2. People with uncontrolled tumor-related pain as judged by the investigator
3. Risk of major bleeding as assessed by investigators
4. Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function
5. Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy 6:History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin));
7：Women who are pregnant or breastfeeding; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year of the cell return.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05430360
Study Brief:
Protocol Section:
NCT05430360