What is the mechanism of action of this treatment?

Common treatments for Mesothelioma, such as the use of Autologous Tumor-Infiltrating Lymphocytes (TILs) and High-Dose Aldesleukin, leverage the body's immune system to target and destroy cancer cells. TILs are extracted from the patient's tumor, expanded in vitro, and then reinfused to attack the cancer cells directly. High-Dose Aldesleukin (IL-2) supports the growth and activation of these TILs, enhancing their ability to combat the tumor. This approach is significant for Mesothelioma patients as it offers a targeted treatment option that can potentially improve outcomes by harnessing the body's natural defenses against cancer.

What side effects are associated with this type of intervention?

Common side effects of treatments for mesothelioma, particularly those involving adoptive cell therapy with autologous TILs and high-dose aldesleukin, include cytokine release syndrome (CRS) characterized by fever, fatigue, and low blood pressure. High-dose aldesleukin can cause severe side effects such as capillary leak syndrome, resulting in low blood pressure, fluid retention, and organ dysfunction. Other potential side effects include nausea, vomiting, diarrhea, and an increased risk of infections due to immune system modulation.

What prior FDA approvals exist?

The FDA has approved several treatments for Mesothelioma, primarily focusing on chemotherapy and immunotherapy. Pemetrexed in combination with cisplatin was one of the first approved treatments. More recently, the FDA approved the combination of nivolumab and ipilimumab, which are immune checkpoint inhibitors that enhance the body's immune response against cancer cells. While there are no specific FDA approvals for treatments exactly like Autologous TIL and High-Dose Aldesleukin for Mesothelioma, these approvals reflect a growing interest in immunotherapy approaches that activate and support the immune system to target cancer cells.

What other types of research exist?

Promising novel alternatives for Mesothelioma patients include immune checkpoint inhibitors targeting PD-1 and PD-L1, such as pembrolizumab and avelumab. These therapies have shown some efficacy in clinical trials and may offer a viable option for treatment in 2024.

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CAR T-cell Therapy

TIL Therapy for Advanced Cancer

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

Must not have

Women of child-bearing potential who are pregnant or breastfeeding

Active systemic infections

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a treatment for advanced cancers that haven't responded to standard treatments. It involves reducing the patient's immune cells, then using their own enhanced immune cells to fight the cancer, supported by a drug that boosts immune activity.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am pregnant or breastfeeding.

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I currently have an infection that affects my whole body.

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I have a serious blood clotting disorder.

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I have a serious autoimmune disease affecting major organs.

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I am currently taking steroid medication.

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I have had heart problems like chest pain or heart attacks.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Complete Response Rate (CRR)

Disease control rate (DCR)

Duration of response (DOR)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 16Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Mesothelioma, such as the use of Autologous Tumor-Infiltrating Lymphocytes (TILs) and High-Dose Aldesleukin, leverage the body's immune system to target and destroy cancer cells. TILs are extracted from the patient's tumor, expanded in vitro, and then reinfused to attack the cancer cells directly. High-Dose Aldesleukin (IL-2) supports the growth and activation of these TILs, enhancing their ability to combat the tumor. This approach is significant for Mesothelioma patients as it offers a targeted treatment option that can potentially improve outcomes by harnessing the body's natural defenses against cancer.

Novel and Future Treatment Options in Mesothelioma: A Systematic Review.Predictive and prognostic significance of tumor-infiltrating lymphocytes in patients with breast cancer treated with neoadjuvant systemic therapy.