TIL Cells for the Treatment of the Advanced Solid Tumors Patients

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: Cyclophosphamide Capsules; Biological: Tumor Infiltrating Lymphocytes; Drug: Fludarabine; Drug: IL-2

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.

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Meifang Li; Phone Number: 15985795022; Email: 362952772@qq.com
• Study Contact Backup: Name: Zhiyong He; Phone Number: 13805086391; Email: heyong1015@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Event	The severity and incidence of various adverse events and serious adverse events	up to 24 months
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS)	up to 24 months
Overall response rate(ORR)	up to 24 months
Progression free survival (PFS)	up to 24 months

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital
• Investigators: Principal Investigator: zhiyong He, Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 5, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2026

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: December 11, 2022
• First Posted (Actual): December 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide; Fludarabine
• Other Study ID Numbers: FJ001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No