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CAR T-cell Therapy

Adoptive Cell Therapy for Sarcoma

Phase 1
Waitlist Available
Led By John Mullinax, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must fulfill all of the following criteria to be eligible for the study at the time of tumor resection and initiation of TIL expansion.
Participants must have metastatic, high-grade soft tissue sarcoma, all subtypes will be eligible.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights

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.

Who is the study for?
This trial is for adolescents and young adults with high-grade soft tissue sarcoma who have tried at least one standard treatment. They must be in fairly good health, not pregnant or nursing, and free from serious infections or immune system diseases. Participants should not need chronic steroids, have autoimmune diseases requiring immunosuppression, or active brain metastases.Check my eligibility
What is being tested?
The trial tests Tumor-infiltrating lymphocyte (TIL) therapy combined with drugs Cyclophosphamide, Interleukin-2, and Fludarabine to see if they're safe and how well the TILs survive after treatment. It's a single-arm study where all participants receive the same experimental therapy.See study design
What are the potential side effects?
Possible side effects include reactions to cell infusions like fever or chills; damage to organs due to high-dose interleukin-2; low blood counts leading to increased infection risk; nausea from chemotherapy drugs; fatigue; and potential urinary tract issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I meet all the requirements for the study at the time of my tumor removal and TIL expansion.
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I have a high-grade, metastatic soft tissue sarcoma.
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My condition worsened after treatment for my spreading cancer.
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I still have visible cancer after surgery aimed at growing immune cells.
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I have tested positive for EBV antibodies.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants who experienced Serious Adverse Events and Adverse Events
Secondary outcome measures
Number of participants with circulating tumor-infiltrating lymphocytes (TIL) product at 6 weeks
Number of participants with objective antitumor response

Trial Design

1Treatment groups
Experimental Treatment
Group I: Infusion of Tumor-infiltrating lymphocyteExperimental Treatment4 Interventions
Participants will undergo tumor resection from which the tumor infiltrating lymphocyte (TIL) product will be generated. All participants will receive nonmyeloablative lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T-cell persistence and effectiveness in vivo. Cyclophosphamide will be administered at 60 mg/kg/day IV in 250 mL normal saline (NS). Fludarabine will then be infused at 25 mg/m^2 intravenous piggyback (IVPB). All participants will receive not less than 10^9, and up to 1x10^12 T cells in ≥250 mL NS as an inpatient by intravenously (IV). Eight (8) to sixteen (16) hours after completing the T cell infusion, all participants will receive high-dose interleukin-2 (IL-2) on an inpatient basis at the standard dose of 600 000 IU/kg as an intravenous bolus over an approximate 15-minute period every 8 to 16 hours for up to 15 doses on days 1 to 5, as tolerated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3770
Interleukin-2
1994
Completed Phase 3
~700
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Industry Sponsor
20 Previous Clinical Trials
1,686 Total Patients Enrolled
1 Trials studying Sarcoma
30 Patients Enrolled for Sarcoma
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
542 Previous Clinical Trials
135,482 Total Patients Enrolled
8 Trials studying Sarcoma
253 Patients Enrolled for Sarcoma
National Cancer Institute (NCI)NIH
13,660 Previous Clinical Trials
40,924,262 Total Patients Enrolled
453 Trials studying Sarcoma
230,045 Patients Enrolled for Sarcoma

Media Library

Tumor-infiltrating lymphocyte (TIL) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04052334 — Phase 1
Sarcoma Research Study Groups: Infusion of Tumor-infiltrating lymphocyte
Sarcoma Clinical Trial 2023: Tumor-infiltrating lymphocyte (TIL) Highlights & Side Effects. Trial Name: NCT04052334 — Phase 1
Tumor-infiltrating lymphocyte (TIL) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04052334 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I fulfill the conditions to partake in this clinical experiment?

"This clinical trial is open to 10 people aged 18-39 with sarcoma who meet the following criteria: Eastern Cooperative Oncology Group (ECOG) 0 to 1; ECOG performance status of 0 to 1 inferred if patient's energy level is ≥ 50% of baseline; negative pregnancy test for women of childbearing potential at screening; willingness and availability to comply with all study procedures, as well as having progressed on one standard prior care treatment regimen."

Answered by AI

What is the maximum capacity for this research project?

"Unfortunately, this medical trial has closed its recruitment period; it was initially noticed on September 27th 2019 and went through a final editing process on November 10th 2022. However, there are currently 443 clinical trials for sarcoma patients and 901 TIL studies that can accept participants."

Answered by AI

Has there been any precedent for the application of TIL in research studies?

"At the present time, there are 901 research studies that are utilizing TIL as part of their protocol. Out of these trials, 161 have entered Phase 3 testing. Of these 161 trails, most are located in Philadelphia but they span 28476 sites across the globe."

Answered by AI

What medical purpose is tumor infiltrating lymphocytes usually used for?

"TIL is often used to mitigate multiple sclerosis, but it also has applications for acute leukemia, myelocytic lymphoma, retinoblastoma, and histiocytosis."

Answered by AI

What risks do individuals face when undergoing TIL treatment?

"TIL's safety is presumed to be high, as it has only been in the first phase of clinical trials. Thus, our analysis assigns a score of 1 for this drug’s safety profile."

Answered by AI

Are there still vacancies for participants in this investigation?

"Unfortunately, this particular study has ceased recruitment of patients. It was originally made available on September 27th 2019 and the last changes were recorded November 10th 2022. However, there are currently 443 clinical trials actively seeking sarcoma patient participants as well as 901 recruiting for TIL therapy."

Answered by AI

Does this investigation include individuals aged 40 or older?

"The requirements for this clinical trial necessitate that participants must be between 18-39 years old. By contrast, there are 468 trials available to those below the age of consent and 1041 studies appropriate for individuals older than 65."

Answered by AI
~2 spots leftby Apr 2025