TIL Cells for the Treatment of the Advanced Solid Tumors Patients

Solid Tumor Clinical Trial

Official title:

A Single-center, Open-label Clinical Study of TIL Cells for the Treatment of the Recurrent/Metastatic Solid Tumors Patients Who Had Failed Standard Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05649618
• Other study ID #: FJ001
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: December 5, 2022
• Est. completion date: March 2026

Study information

• Verified date: December 2022
• Source: Fujian Cancer Hospital
• Contact: meifang Li
• Phone: 15985795022
• Email: 362952772[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: March 2026
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• Tumor Infiltrating Lymphocytes
On day 0 patients will be intravenous infusion of TILs

Drug:
• Fludarabine
Part of the non-myeloablative lymphocyte-depleting preparative regimen
• Cyclophosphamide Capsules
Part of the non-myeloablative lymphocyte-depleting preparative regimen.
• IL-2
Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limiting Toxicity	Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TILs therapy.	up to Day 28
Primary	Adverse Event	The severity and incidence of various adverse events and serious adverse events	up to 24 months
Secondary	Overall response rate(ORR)		up to 24 months
Secondary	Progression free survival (PFS)		up to 24 months
Secondary	Overall survival (OS)		up to 24 months