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 is a single-center, open-label, Phase I clinical study of TCR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.

TCR-T cells are expanded from peripheral blood, and after ex vivo modification, and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

The primary purpose of this study is to evaluate the safety and tolerability of TCR-T cells in patients with recurrent/metastatic solid tumors.

The second purpose of this study is to preliminarily explore the effectivenes...

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.

Trial Officials