TIL Cells for the Treatment of the Advanced Solid Tumors Patients

Fujian Provincial Cancer Hospital

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Solid Tumor

Treatments: Biological: Tumor Infiltrating Lymphocytes; Drug: IL-2; Drug: Fludarabine; Drug: Cyclophosphamide Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT05649618

FJ001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

42 participants in 1 patient group

Tumor Infiltrating Lymphocytes

Experimental group

Description:

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.

Treatment:

Drug: Cyclophosphamide Capsules

Biological: Tumor Infiltrating Lymphocytes

Drug: Fludarabine

Drug: IL-2