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CAR T-cell Therapy

TIL Therapy for Advanced Cancer

Q: To whom does the eligibility criteria for this medical study apply?

<p>This investigation seeks 10 adults with <a href="https://www.withpower.com/clinical-trials/mesothelioma">mesothelioma</a>, aged 18 to 75. To be considered for the study, participants must have already enrolled in protocol <a href="https://www.withpower.com/clinical-trials/hcc">HCC</a> 17-220 and possess TIL cultures ready for therapy. Their clinical performance status should be an ECOG 0 or 1, while those with locally advanced disease need to not qualify as resectable by traditional surgical procedures. Those with distant metastatic spread ought to have been eligible for approved first line systemic treatments prior joining this trial. Eligible patients can also include those who had 3 or less brain metastases of under 1cm diameter that are presently symptomless; however they must</p>

Phase 2

Recruiting

Led By Udai S Kammula, MD

Research Sponsored by Udai Kammula

Eligibility Criteria Checklist

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

Must have

Patients of both genders who are of child-bearing potential must be willing to practice birth control

More than four weeks must have elapsed since any prior systemic therapy at the time the patient receives the preparative regimen, and patients' toxicities must have recovered to a clinically manageable level

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new treatment for cancer that involves removing some lymph nodes, infusing the patient with their own tumor cells, and then giving them a high dose of aldesleukin. The goal is to see if this can help patients with locally advanced, recurrent, or metastatic cancer.

Who is the study for?

This trial is for adults aged 18-75 with certain advanced solid cancers, like pancreatic or colorectal cancer, who've tried all standard treatments. They must have a good performance status and life expectancy over three months. Women of childbearing age need a negative pregnancy test and agree to birth control.Check my eligibility

What is being tested?

The study tests Tumor Infiltrating Lymphocytes (TIL) therapy combined with Fludarabine and Cyclophosphamide in patients with specific advanced cancers. It's checking how well this approach works after patients have had no success with conventional therapies.See study design

What are the potential side effects?

Possible side effects include reactions from the immune system such as fever or fatigue, risks from chemotherapy like nausea or low blood counts, and potential complications related to organ inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I am willing to use birth control during the trial.

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It's been over 4 weeks since my last systemic therapy, and any side effects are under control.

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

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My cancer cannot be removed with standard surgery.

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My cancer has spread or returned and can be measured.

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I am a woman who can have children and my pregnancy test is negative.

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I am enrolled in the HCC 17-220 study and have TIL cultures ready for therapy.

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I have up to 3 small brain tumors that don't cause symptoms.

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I had surgery to remove brain metastases.

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I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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

Objective Response Rate (ORR)

Secondary outcome measures

Complete Response Rate (CRR)

Disease control rate (DCR)

Duration of response (DOR)

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Tumor Infiltrating Lymphocytes (TIL)Experimental Treatment2 Interventions

Patients with locally advanced, recurrent, or metastatic gastric/esophagogastric, colorectal, pancreatic, sarcoma, mesothelioma, neuroendocrine, cutaneous/anal squamous cell, Merkel cell, cancers refractory to systemic therapy, and those with deficient mismatch repair and/or microsatellite instability cancers will receive the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of up to 2x10^11 lymphocytes infused through a central vein catheter and administered at a dose of 600,000 IU/kg (based on total body weight) as an intravenous bolus over a 15-minute period approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to a maximum of 6 doses.

0 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

Udai KammulaLead Sponsor

2 Previous Clinical Trials

106 Total Patients Enrolled

Udai S Kammula, MDPrincipal InvestigatorUPMC Hillman Cancer Center

1 Previous Clinical Trials

47 Total Patients Enrolled

Media Library

Tumor Infiltrating Lymphocytes (TIL) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03935893 — Phase 2

Stomach Cancer Research Study Groups: Tumor Infiltrating Lymphocytes (TIL)

Stomach Cancer Clinical Trial 2023: Tumor Infiltrating Lymphocytes (TIL) Highlights & Side Effects. Trial Name: NCT03935893 — Phase 2

Tumor Infiltrating Lymphocytes (TIL) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03935893 — Phase 2

Frequently Asked Questions

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

What maladies have been treated most effectively with the Fludarabine + Cyclophosphamide combination?

"The combination of Fludarabine and Cyclophosphamide has been found to be effective in treating multiple sclerosis, mixed-cell type lymphoma, as well as acute myelocytic leukemia."

Answered by AI

Have prior experiments explored the potential of Fludarabine and Cyclophosphamide in tandem?

"Currently, there are 889 active clinical trials examining the efficacy of Fludarabine + Cyclophosphamide in unison. Of these studies, 161 have reached phase 3. These medical research sites can be found across 28443 locations worldwide; however most of them reside within Philadelphia, Pennsylvania."

Answered by AI

Is this clinical trial open to individuals who are younger than 75?

"To participate in this trial, patients must fit within an age range of 18 to 75. Separately, 535 studies are available for those under the legal age and 3131 trials exist for seniors over 65 years old."

Answered by AI

Is there availability for volunteers to join this clinical experiment?

"Affirmative. The information hosted on clinicaltrials.gov reveals that this investigation, which was originally posted on December 3rd 2019, is actively recruiting contributors. Approximately 10 individuals must be recruited from 1 medical centre."

Answered by AI

What potential risks might be associated with the Fludarabine + Cyclophosphamide combination?

"This Phase 2 medical trial assessing the safety of Fludarabine and Cyclophosphamide in combination is estimated to be safe, thus receiving a score of two. Therefore, there exists some data supporting its safety but none demonstrating efficacy."

Answered by AI

What is the current limit of participants for this clinical exploration?

"Affirmative. Clinicaltrials.gov reflects that this clinical trial, initially posted on December 3rd 2019, is actively seeking participants. 10 patients are needed from one medical centre."

Answered by AI

To whom does the eligibility criteria for this medical study apply?

"This investigation seeks 10 adults with mesothelioma, aged 18 to 75. To be considered for the study, participants must have already enrolled in protocol HCC 17-220 and possess TIL cultures ready for therapy. Their clinical performance status should be an ECOG 0 or 1, while those with locally advanced disease need to not qualify as resectable by traditional surgical procedures. Those with distant metastatic spread ought to have been eligible for approved first line systemic treatments prior joining this trial. Eligible patients can also include those who had 3 or less brain metastases of under 1cm diameter that are presently symptomless; however they must"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers

Udai Kammula 2019. "Adoptive Transfer of Tumor Infiltrating Lymphocytes for Advanced Solid Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03935893.

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