Treatment using engineered T cells for patients with advanced solid tumors expressing NY-ESO-1

A Phase I/II Clinical Study of TC-N201 Injection for the Treatment of Advanced Solid Tumors With HLA-A2 Expression and Positive NY-ESO-1.

This study is testing a new treatment that uses modified T cells to see if it can help patients with advanced solid tumors that haven't responded to other therapies.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: TCRCure Biopharma Ltd. (Industry-sponsored)
• Drugs / interventions: CAR-T
• Locations: 1 site (Chongqing)
• Trial ID: NCT05881525 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of NY-ESO-1 TCR-T cells in patients with advanced solid tumors that have not responded to standard therapies. The process involves collecting a patient's T cells, genetically modifying them to target the NY-ESO-1 protein, and then re-infusing these engineered cells back into the patient. The study is conducted at a single center and includes various screening tests to ensure patient eligibility. Participants will be closely monitored during their hospital stay after receiving the treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with advanced solid tumors that express NY-ESO-1 and have failed standard treatments.

Not a fit: Patients with solid tumors that do not express NY-ESO-1 or those who are not HLA-A2 positive may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors, potentially improving survival rates.

How similar studies have performed: Other studies utilizing TCR-T cell therapy have shown promising results, indicating potential success for this approach.

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.

Where this trial is running

Chongqing

• TCRCure Biopharma Ltd. — Chongqing, China (Recruiting)

Study contacts

• Principal investigator: ning Li, PhD — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: ning Li, PhD

Conditions Advanced Solid Tumors