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CAR T-cell Therapy

Immunotherapy with TIL for Cancer

Phase 2

Recruiting

Led By Steven A Rosenberg, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 72 years

Measurable metastatic cancer of specific types: upper or lower gastrointestinal, hepatobiliary, genitourinary, breast, ovarian/endometrial, or endocrine tumors including neuroendocrine tumors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose

Awards & highlights

Study Summary

This trial is testing a new experimental therapy to see if it can cause tumors to shrink in people with digestive tract, urothelial, breast, or ovarian/endometrial cancers. The therapy involves taking white blood cells from patients' tumors, growing them in the laboratory, and then giving the cells back to the patient.

Who is the study for?

Adults aged 18-72 with certain types of metastatic cancer (digestive tract, breast, ovarian/endometrial, etc.) who haven't responded to standard treatments. Participants must not have HIV or hepatitis, agree to birth control and testing if applicable, and be in relatively good health otherwise.Check my eligibility

What is being tested?

The trial is testing a therapy where white blood cells from the patient's tumor are grown in large numbers and reinfused into them. The study aims to see if these Tumor Infiltrating Lymphocytes (TIL) can shrink tumors effectively and safely.See study design

What are the potential side effects?

Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions from the cell transfer process, fatigue due to high cell growth activity, and complications from chemotherapy drugs used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 72 years old.

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My cancer is metastatic and falls into one of the specified categories.

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I have up to 3 small, symptom-free brain tumors.

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My cancer did not respond to standard treatments.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 6 weeks (week 6, 12, 18, 24) within 24 hours prior to next scheduled pembrolizumab dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Response rate

Secondary outcome measures

Frequency and severity of treatment-related adverse events

Safety and efficacy of pembrolizumab in combination with TIL therapy

Trial Design

4Treatment groups

Experimental Treatment

Group I: 4/Unselected TIL + Pembro at PODExperimental Treatment5 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young unselected TIL + high-dose aldesleukin + pembrolizumab within 4 weeks of progressive disease for up to 8 doses every 3 weeks

Group II: 3/Unselected TIL + Pembro Prior to CellsExperimental Treatment5 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young unselected TIL + high-dose aldesleukin + pembrolizumab prior to cell administration and 3 additional doses every 3 weeks following cell infusion

Group III: 2/Unselected TIL (CLOSED)Experimental Treatment4 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young unselected TIL + high-dose aldesleukin (CLOSED)

Group IV: 1/CD8+ Enriched TIL (CLOSED)Experimental Treatment4 Interventions

Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine + young CD8+ enriched TIL + high-dose aldesleukin (CLOSED)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cyclophosphamide

1995

Completed Phase 3

~3770

Young TIL

2012

Completed Phase 2

~70

Aldesleukin

2012

Completed Phase 4

~1620

Pembrolizumab (Keytruda)

2020

Completed Phase 1

~10

Fludarabine

2012

Completed Phase 3

~1100

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,665 Previous Clinical Trials

40,925,522 Total Patients Enrolled

286 Trials studying Ovarian Cancer

73,766 Patients Enrolled for Ovarian Cancer

Steven A Rosenberg, M.D.Principal InvestigatorNational Cancer Institute (NCI)

37 Previous Clinical Trials

17,549 Total Patients Enrolled

5 Trials studying Ovarian Cancer

496 Patients Enrolled for Ovarian Cancer

Media Library

Young TIL (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01174121 — Phase 2

Ovarian Cancer Research Study Groups: 4/Unselected TIL + Pembro at POD, 2/Unselected TIL (CLOSED), 1/CD8+ Enriched TIL (CLOSED), 3/Unselected TIL + Pembro Prior to Cells

Ovarian Cancer Clinical Trial 2023: Young TIL Highlights & Side Effects. Trial Name: NCT01174121 — Phase 2

Young TIL (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01174121 — Phase 2

Frequently Asked Questions

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

Are participants of this research study limited to those aged 18 and above?

"This medical study only accepts individuals aged 18 to 72. For minors, there are 774 relevant studies and for seniors, 7033 trials may be applicable."

Answered by AI

Are individuals currently eligible to join this trial?

"As evidenced on clinicaltrials.gov, this medical trial is presently accepting participants. This research project was initially advertised in August of 2010 and its details have been recently updated as of November 15th 2022."

Answered by AI

What other investigations have been completed using Young TIL as a tool?

"Currently, 1838 studies are underway to examine Young TIL. Of these live trials, 283 have reached the third and final stage of experimentation. Philadelphia is home to most of these experiments, though many other sites across the USA also offer access to this therapy."

Answered by AI

How many participants are being evaluated in this investigation?

"Correct. The records on clinicaltrials.gov demonstrate that this medical study, which was initially posted on August 26th 2010, is actively recruiting individuals. It requires 332 participants to be sourced from two distinct sites."

Answered by AI

In what medical scenarios is Young TIL prescribed?

"Young TIL is a popular treatment option for non-Hodgkin lymphoma, though it may also be employed to treat malignant melanoma of skin, recurrent cervical cancer and leukemia."

Answered by AI

Is there an opportunity for me to participate in this research project?

"This clinical trial is searching for 332 people between 18 and 72 years old that have been diagnosed with glioblastoma. Applicants must also meet the following qualifications: evidence of metastatic cancer meeting RECIST v1.0 criteria, lesion resectable for TIL generation via minimal invasive laparoscopic or thoracoscopic surgery, confirmation of diagnosis by NCI Laboratory of Pathology; oxaliplatin/irinotecan use in colorectal cancer, sorafenib (Nexavar) treatment to hepatocellular carcinoma patients; refractoriness to first and second line treatments plus one"

Answered by AI

What implications does the application of Young TIL have for patient safety?

"Young TIL's safety was assessed as a 2, since this is merely a Phase 2 trial - there exists data supporting the drug’s security but none for its efficacy."

Answered by AI

Recent research and studies

Annals of SurgeryJournal

Clinical Score for Predicting Recurrence After Hepatic Resection for Metastatic Colorectal Cancer

Fong, Yuman, Joseph Fortner, Ruth L. Sun, Murray F. Brennan, and Leslie H. Blumgart. 1999. “Clinical Score for Predicting Recurrence After Hepatic Resection for Metastatic Colorectal Cancer”. Annals of Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/00000658-199909000-00004.

ScienceJournal

Cancer Immunotherapy Based on Mutation-specific CD4+ T Cells in a Patient with Epithelial Cancer

Tran, Eric, Simon Turcotte, Alena Gros, Paul F. Robbins, Yong-Chen Lu, Mark E. Dudley, John R. Wunderlich, et al.. 2014. “Cancer Immunotherapy Based on Mutation-specific CD4+ T Cells in a Patient with Epithelial Cancer”. Science. American Association for the Advancement of Science (AAAS). doi:10.1126/science.1251102.

Journal of Clinical OncologyJournal

Actual 10-year Survival After Resection of Colorectal Liver Metastases Defines Cure

Tomlinson, James S., William R. Jarnagin, Ronald P. DeMatteo, Yuman Fong, Peter Kornprat, Mithat Gonen, Nancy Kemeny, Murray F. Brennan, Leslie H. Blumgart, and Michael D'Angelica. 2007. “Actual 10-year Survival After Resection of Colorectal Liver Metastases Defines Cure”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2007.11.0833.

Journal of Clinical InvestigationJournal