NCT05649618

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2022

Typical duration for early_phase_1

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

December 5, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 14, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 14, 2022

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

October 26, 2022

Last Update Submit

December 11, 2022

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

  • 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

  • Adverse Event

    The severity and incidence of various adverse events and serious adverse events

    up to 24 months

Secondary Outcomes (3)

  • Overall response rate(ORR)

    up to 24 months

  • Progression free survival (PFS)

    up to 24 months

  • Overall survival (OS)

    up to 24 months

Study Arms (1)

Tumor Infiltrating Lymphocytes

EXPERIMENTAL

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.

Biological: Tumor Infiltrating LymphocytesDrug: FludarabineDrug: Cyclophosphamide CapsulesDrug: IL-2

Interventions

Tumor Infiltrating LymphocytesBIOLOGICAL

On day 0 patients will be intravenous infusion of TILs

Tumor Infiltrating Lymphocytes
FludarabineDRUG

Part of the non-myeloablative lymphocyte-depleting preparative regimen

Tumor Infiltrating Lymphocytes
Cyclophosphamide CapsulesDRUG

Part of the non-myeloablative lymphocyte-depleting preparative regimen.

Tumor Infiltrating Lymphocytes
IL-2DRUG

Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance.

Tumor Infiltrating Lymphocytes

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;
  • \~ 75 years;
  • The expected survival period is at least 3 months;
  • ECOG score of 0-1;
  • There is at least one lesion that can be operated or biopsied for the preparation of TIL;
  • According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;
  • Patients with recurrent or metastatic solid tumors confirmed by histopathology;
  • 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

You may not qualify if:

  • Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline ;
  • Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;
  • 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;
  • 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;
  • Patients who have received adoptive cell therapy in the past;
  • According to the judgment of the investigator, the condition of the subject is not suitable for this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

fludarabineCyclophosphamideInterleukin-2

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsInterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Officials

  • zhiyong He

    Fujian Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

meifang Li

CONTACT

15985795022362952772@qq.com

zhiyong He

CONTACT

13805086391heyong1015@163.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2022

First Posted

December 14, 2022

Study Start

December 5, 2022

Primary Completion

March 1, 2024

Study Completion

March 1, 2026

Last Updated

December 14, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share