TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors

Launched by FUJIAN CANCER HOSPITAL · Dec 12, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for patients with advanced solid tumors that express a specific protein called NY-ESO-1. This protein is found in various types of tumors, and researchers are using a special method to modify patients' own immune cells (called TCR-T cells) to better recognize and attack these tumors. The goal is to see if this treatment can help shrink tumors or extend the lives of patients who have not responded to standard therapies.

To participate in this trial, patients need to be between 18 and 70 years old, have a confirmed diagnosis of a solid tumor that shows NY-ESO-1 positivity, and have measurable tumor lesions. They should also be willing and able to communicate with the research team and follow the study requirements. Participants can expect to receive the modified T cells through an infusion, and the trial is currently not recruiting, meaning they will start enrolling patients soon. It's important for potential participants to know that certain health conditions or previous treatments might make them ineligible for this study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;
• • 2. 18 \~70 years old (gender is not limited;)
• • 3. The expected survival period is at least 3 months;
• • 4. ECOG score of 0-1;
• • 5. Patients with recurrent or metastatic solid tumors confirmed by histopathology;
• • 6. Subjects who failed standard treatment in the past or have no standard treatment currently tor who are judged by the investigator to be unsuitable for current standard treatment for other reasons, and the objective imaging assessment is disease progression;
• • 7. According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;
• • 8. NY-ESO-1 positive;
• • 9. HLA type is HLA-A2 (except HLA-A\*0203);
• Exclusion Criteria:
• • 1. Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline;
• • 2. Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;
• • 3. Subjects who have received any investigational drug within 28 days before the infusion of TIL cells, or participated in another clinical study at the same time;
• • 4. Subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma;
• • 5. Patients who have received adoptive cell therapy in the past;
• • 6. According to the judgment of the investigator, the condition of the subject is not suitable for this trial.