NCT05881525 NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors
| NCT ID | NCT05881525 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | TCRCure Biopharma Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 18 participants in total. It began in 2023-06-01 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a cancer-testis antigen (CTA) which is expressed in various tumors. In TCR-T therapy, researchers take the blood of a certain patient, select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. The genetically engineered cells are called NY-ESO-1 TCR-T cells. Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life.
Eligibility Criteria
Inclusion Criteria: * Be able to understand and sign the Informed of Consent Document. Be willing to follow the procedure and protocol of the clinical trial; * Age ≥ 18 years and ≤ 70 years; * Expected survival time \> 3 months; * ECOG score 0-1; * Metastatic or recurrent solid tumors confirmed by histopathology; * Refractory to standard treatment evaluated by radiological assessment; * Be able provide fresh or preserved tissue specimen; * At least 1 measurable lesion (according to RECIST 1.1); * NY-ESO-1 expression positive: Immunohistochemical staining positive cells ≥25% and positive staining intensity is "++" or above; * HLA typing is HLA-A2 (excluding HLA-A\*0203); * Hematology should at least meet the following criteria: 1. Absolute neutrophil count (ANC) ≥ 1.5× 109/L (±20%)； 2. Platelet (PLT） ≥ 75× 109/L (±20%）； 3. Hemoglobin (HGB) ≥ 90 g/L (±20%). * Liver and kidney function are normal: 1. Serum creatinine (Cr) ≤ 1.5 times of upper limit of normal (ULN) or creatine clearance ≥ 60 ml/min; 2. Serum Alanine aminotransferase (ALT) or/and Aspartate aminotransferase (AST) ≤ 2.5 times of upper limit of normal; 3. Total bilirubin (TBIL) ≤ 15 times of upper limit of normal. * Blood coagulation function is normal: Prothrombin time (PT) ≤ 1.5 ULN, International Normalized Ratio (INR) ≤ 1.5 ULN, or Activated Partial Thromboplastin Time (APTT) ≤ 1.5 ULN; * Echocardiogram results show: Left ventricular ejection fraction \>45%; * Women of childbearing potential should be ascetic or take contraception since the signing of ICF to 24 weeks or later after the last administration of drug Note: Women of childbearing age who have undergone surgical sterilization or who have already experienced menopause are considered to have no possibility of pregnancy. * Before the TC-N201 injection was reconstituted, the toxic effects of standard treatment had already recovered, and the corresponding adverse events were judged by the researcher to not pose a safety risk; * Catheter insertion is feasible and No White Blood Cells collection contraindications. Exclusion Criteria: * Under pregnancy or lactation, or positive based on blood pregnancy test; * Severe allergic to related ingredients in the clinical trial; * Received any other investigational treatment within 4 weeks before the first administration or enrolled in another clinical trial the same time; * History of other known malignant tumors within the previous 5 years, including carcinoma in situ of the cervix, basal cell carcinoma of the skin, and carcinoma in situ of the prostate; Except for localized tumors that have been cured; * Primary central nerve system (CNS) cancer, or subjects with CNS metastasis after localized treatment; * Subjects with any active autoimmune disease, a history of autoimmune disease, or a history or syndrome requiring treatment with systemic steroids or immunosuppressive drugs; * Immunodeficiency including HIV positive, harvested or natural immunodeficiency; * Subjects with ≥ grade 3 thromboembolic events within 2 years or under thrombolysis treatment; * Subjects with hereditary or acquired hemorrhagic disease; * Have clinical cardiovascular disease or symptoms; * Subjects with active infection: active infection requiring systemic anti-infective treatment (except topical antibiotics), fever caused by cancer could be enrolled according to the investigator's judgment; * Subjects with active pulmonary tuberculosis infection detected by medical history or Computed Tomography (CT), or a history of active pulmonary tuberculosis infection within 1 year before enrollment, or a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment; * Subjects with positive hepatitis B surface antigen or positive hepatitis B core antibody or positive hepatitis C virus antibody; * Treponema pallidum antibody positive; * Subjects received major surgery or under severe injury within 4 weeks before TC-N201 cell infusion; * Subjects who received live vaccine or attenuated live vaccine 28 days before leukapheresis; * Subjects who have drug addiction history, or alcoholism, drug users; * Subjects who received cell therapy before enrollment，such as TCR-T，CAR-T and TIL; * Subjects who have previously received treatment targeting NY-ESO-1; * Subjects not suitable for the clinical trial according to investigators.
Contact & Investigator
ning Li, PhD
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT05881525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05881525 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05881525 currently recruiting?
Yes, NCT05881525 is actively recruiting participants. Contact the research team at lining@cicams.ac.cn for enrollment information.
Where is the NCT05881525 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT05881525 clinical trial?
NCT05881525 is sponsored by TCRCure Biopharma Ltd.. The principal investigator is ning Li, PhD at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 18 participants.