TIL Cells for the Treatment of the Advanced Solid Tumors Patients

NCT ID: NCT05649618

Last Updated: 2022-12-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-05
• Study Completion Date: 2026-03-31

Brief Summary

This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TILs) therapy in patients with Advanced malignant solid tumors. TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

Detailed Description

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

TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation 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 TILs in patients with recurrent/metastatic solid tumors.

The second purpose of this study is to preliminarily explore the effectiveness of TILs in patients with recurrent/metastatic solid tumors.

Eligibility:

Adults aging 18-75 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.

Conditions

Solid Tumor

Study Design

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

Study Groups

Tumor Infiltrating Lymphocytes

TIL cells (2.5×10\^9-5×10\^10) will be infused i.v. to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.

Group Type: EXPERIMENTAL

Tumor Infiltrating Lymphocytes

Intervention Type: BIOLOGICAL

On day 0 patients will be intravenous infusion of TILs

Fludarabine

Intervention Type: DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regimen

Cyclophosphamide Capsules

Intervention Type: DRUG

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

IL-2

Intervention Type: DRUG

Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance.

Interventions

Tumor Infiltrating Lymphocytes

On day 0 patients will be intravenous infusion of TILs

Intervention Type: BIOLOGICAL

Fludarabine

Part of the non-myeloablative lymphocyte-depleting preparative regimen

Intervention Type: DRUG

Cyclophosphamide Capsules

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Intervention Type: DRUG

IL-2

Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance.

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 ~ 75 years;

3. The expected survival period is at least 3 months;

4. ECOG score of 0-1;

5. There is at least one lesion that can be operated or biopsied for the preparation of TIL;

6. According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;

7. Patients with recurrent or metastatic solid tumors confirmed by histopathology;

8. 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

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: 75 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

FJ001

Identifier Type: -

Identifier Source: org_study_id