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

• Status: Not yet recruiting
• Trial end date: 2026-03-01
• Target enrollment: 0
• Participant gender: All

Summary

New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Then the engineered cells are re-infused in the patients with tumors for curing the tumor patient or prolonging life.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Fludarabine; Paclitaxel

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.