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TIL Cells for the Treatment of the Advanced Solid Tumors Patients

NCT05649618 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-12-14

No results posted yet for this study

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.

Conditions

Interventions

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

Cyclophosphamide Capsules

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.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • zhiyong He · Fujian Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-05
Primary Completion
2024-03-31
Completion
2026-03-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05649618 on ClinicalTrials.gov