TIL Cells for the Treatment of the Advanced Solid Tumors Patients

Early Phase 1

Not yet recruiting

• Conditions: Solid Tumor
• Interventions: Biological: Tumor Infiltrating Lymphocytes; Drug: Fludarabine; Drug: Cyclophosphamide Capsules; Drug: IL-2

• Registration Number: NCT05649618
• Lead Sponsor: Fujian Cancer Hospital

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.

Study Timeline

• Study First Submitted: 2022-10-26
• Status Verified: 2022-12
• Study Start: 2022-12-05
• Study First Submitted QC: 2022-12-11
• Last Update Submitted: 2022-12-11
• Study First Posted: 2022-12-14
• Last Update Posted: 2022-12-14
• Primary Completion: 2024-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor Infiltrating Lymphocytes	IL-2	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.
Tumor Infiltrating Lymphocytes	Cyclophosphamide Capsules	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.
Tumor Infiltrating Lymphocytes	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.
Tumor Infiltrating Lymphocytes	Fludarabine	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.

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity	up to Day 28	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.
Adverse Event	up to 24 months	The severity and incidence of various adverse events and serious adverse events

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	up to 24 months
Overall survival (OS)	up to 24 months
Overall response rate(ORR)	up to 24 months