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

NCT ID: NCT05648994

Last Updated: 2022-12-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-31
• Study Completion Date: 2026-03-31

Brief 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.

Detailed Description

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 effectiveness of TCR-T cells in patients with recurrent/metastatic solid tumors.

Eligibility:

Adults aging 18-70 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TCR-T cells

TCR-T cells will be infused to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.

Group Type: EXPERIMENTAL

TCR-T cells

Intervention Type: BIOLOGICAL

patients will be administration of TCR-T cells

Fludarabine

Intervention Type: DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regime

Cyclophosphamide Capsules

Intervention Type: DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regime

Albumin-bound paclitaxel

Intervention Type: DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regime

IL-2

Intervention Type: DRUG

Following cell infusion, the patient will be administration high-dose IL-2.

Interventions

TCR-T cells

patients will be administration of TCR-T cells

Intervention Type: BIOLOGICAL

Fludarabine

Part of the non-myeloablative lymphocyte-depleting preparative regime

Intervention Type: DRUG

Cyclophosphamide Capsules

Part of the non-myeloablative lymphocyte-depleting preparative regime

Intervention Type: DRUG

Albumin-bound paclitaxel

Part of the non-myeloablative lymphocyte-depleting preparative regime

Intervention Type: DRUG

IL-2

Following cell infusion, the patient will be administration high-dose IL-2.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiyong He

Role: PRINCIPAL_INVESTIGATOR

Fujian Cancer Hospital

Central Contacts

Meifang Li

Role: CONTACT

Phone: 15985795022

Email: 362952772@qq.com

Zhiyong He

Role: CONTACT

Phone: 13805086391

Email: heyong1015@163.com

Other Identifiers

FJ002

Identifier Type: -

Identifier Source: org_study_id