TIL for Sarcoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarcoma
TIL - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new cancer treatment involving injecting immune cells into tumors. The goal is to see if it is safe and if the immune cells can survive in the body.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Baseline to 12 months

At 12 weeks
Number of participants with objective antitumor response
At 6 weeks
Number of participants with circulating tumor-infiltrating lymphocytes (TIL) product at 6 weeks
Baseline to 12 months
Number of participants who experienced Serious Adverse Events and Adverse Events

Trial Safety

Safety Progress

1 of 3

Trial Design

1 Treatment Group

Infusion of Tumor-infiltrating lymphocyte
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: TIL · No Placebo Group · Phase 1

Infusion of Tumor-infiltrating lymphocyteExperimental Group · 4 Interventions: TIL, Cyclophosphamide, Interleukin-2, Fludarabine · Intervention Types: Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
FDA approved
Human interleukin-2
Not yet FDA approved
Fludarabine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to 12 months

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
489 Previous Clinical Trials
123,360 Total Patients Enrolled
8 Trials studying Sarcoma
283 Patients Enrolled for Sarcoma
The V Foundation for Cancer ResearchOTHER
16 Previous Clinical Trials
4,625 Total Patients Enrolled
1 Trials studying Sarcoma
3,362 Patients Enrolled for Sarcoma
National Cancer Institute (NCI)NIH
12,990 Previous Clinical Trials
41,298,878 Total Patients Enrolled
445 Trials studying Sarcoma
235,714 Patients Enrolled for Sarcoma
Iovance Biotherapeutics, Inc.Industry Sponsor
17 Previous Clinical Trials
1,049 Total Patients Enrolled
1 Trials studying Sarcoma
95 Patients Enrolled for Sarcoma
John Mullinax, MDPrincipal InvestigatorMoffitt Cancer Center

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
and expansion is the main criterion for success After surgically removing all the target lesions for tumor-infiltrating lymphocytes (TIL) to grow and expand, residual measurable disease is the main criterion for success.
This means that a patient's ECOG performance status is 0 to 1 if they have at least 50% of their energy back since their diagnosis.
A MUGA scan is required if your ejection fraction is greater than 50% and you are having lymphodepletion done within 6 months of the scan.
People taking part in the study must have been on at least one previous treatment plan for metastatic cancer.
If a woman is of childbearing potential, she must have a negative pregnancy test (urine or serum) documented at screening.
The patient must have adequate renal, hepatic, and hematologic function, including a creatinine level of less than 1.7 gm/dL, a total bilirubin level of less than 2.0 mg/dL, except for patients with Gilbert's Syndrome who must have a total bilirubin level of less than 3.0 mg/dL, an AST and ALT level of less than 3 X the institutional upper limit of normal, a hemoglobin level of 8 gm/dL or more, 3000 white blood cells per mm^3, and 1000 total granulocytes per mm^3, and a platelet count of 100 000 per mm^3 or more.
Pulmonary function tests should be completed ≤ 6 months prior to lymphodepletion and forced expiratory volume (FEV1) > 65% or FVC > 65% of predicted are required.
To be eligible for the study, participants must have a tumor that can be surgically removed and must begin receiving TIL therapy immediately after the surgery.
I will comply with all study procedures and will be available for the duration of the study.
People with metastatic, high-grade soft tissue sarcoma of any subtype will be eligible to participate.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.