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CAR T-cell Therapy

Tumor Infiltrating Lymphocytes for Uveal Melanoma

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 with surgically resected brain metastases are eligible
Clinical performance status of ECOG 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up : post til infusion up to 24 months (measurements taken at 6 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months 24 months)
Awards & highlights

Study Summary

This trial will test whether a non-myeloablative lymphodepleting preparative regimen followed by infusion of autologous TIL and high-dose aldesleukin is an effective treatment for patients with metastatic uveal melanoma.

Who is the study for?
This trial is for adults aged 18-75 with measurable metastatic uveal melanoma, normal organ function tests, and specific blood count levels. They must not have HIV or hepatitis B/C, be willing to use birth control, and can't be pregnant or breastfeeding. Those with certain heart conditions, severe allergies to study drugs, autoimmune diseases, active infections or on steroids are excluded.Check my eligibility
What is being tested?
The trial studies the effectiveness of Tumor Infiltrating Lymphocytes (TIL) therapy combined with high-dose aldesleukin in patients with metastatic uveal melanoma after a non-myeloablative lymphodepleting regimen. It aims to confirm promising results from a pilot study indicating potential tumor response.See study design
What are the potential side effects?
Potential side effects include reactions related to immune activation such as fever and chills; tissue damage at the infusion site; fatigue; changes in blood pressure due to aldesleukin; possible organ inflammation; and increased risk of infection due to immune system suppression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had surgery to remove cancer that spread to my brain.
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I am fully active or can carry out light work.
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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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My eye melanoma has spread and can be measured.
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I am between 18 and 75 years old.
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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, symptom-free brain tumors.
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My white blood cell count is healthy without needing medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post til infusion up to 24 months (measurements taken at 6 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and post til infusion up to 24 months (measurements taken at 6 weeks, 12 weeks, 6 months, 9 months, 12 months, 18 months 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 Treatment1 Intervention
Patients with uveal melanoma will receive the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide followed by infusion of up to 2x10^11 TIL infused intravenously through a central vein catheter and Aldesleukin, 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 TIL infusion and continuing for up to a maximum of 6 doses.

Find a Location

Who is running the clinical trial?

Udai KammulaLead Sponsor
2 Previous Clinical Trials
299 Total Patients Enrolled
Udai S Kammula, MDPrincipal InvestigatorUPMC Hillman Cancer Center
1 Previous Clinical Trials
240 Total Patients Enrolled

Media Library

Tumor Infiltrating Lymphocytes (TIL) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03467516 — Phase 2
Uveal Melanoma Research Study Groups: Tumor Infiltrating Lymphocytes (TIL)
Uveal Melanoma Clinical Trial 2023: Tumor Infiltrating Lymphocytes (TIL) Highlights & Side Effects. Trial Name: NCT03467516 — Phase 2
Tumor Infiltrating Lymphocytes (TIL) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03467516 — Phase 2

Frequently Asked Questions

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

Are there risks associated with Tumor Infiltrating Lymphocytes (TIL) therapy?

"Tumor Infiltrating Lymphocytes (TIL) is still being studied in Phase 2 clinical trials. While there is some evidence that it may be safe, nothing yet suggests that it is an effective treatment."

Answered by AI

How many total patients are included in this test?

"Yes, according to the latest information on clinicaltrials.gov, this particular trial is still recruiting patients. It was first posted on May 14th, 2018 and was last edited on July 21st, 2022. The study needs a total of 47 participants from 1 location."

Answered by AI

Does this research trial have an age limit?

"This clinical trial is for patients aged 18-75. In comparison, there are 53 trials targeting a younger demographic and 772 trials focusing on an older patient base."

Answered by AI

Are there any available positions for patients in this clinical trial?

"That is correct. The clinicaltrials.gov website contains information indicating that the trial is currently looking for participants. This specific study was posted on May 14th, 2018 and updated as recently as July 21st, 2022. They are hoping to enroll 47 individuals at a single location."

Answered by AI

Are there any ineligibility requirements for this research?

"This study is looking for 47 participants who currently have uveal neoplasms and meet the following criteria: Patients must be co-enrolled on the companion protocol HCC 17-220 (Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies) and have available TIL cultures for therapy., Patients with 3 or fewer brain metastases that are less than 1 cm in diameter and asymptomatic are eligible. Lesions that have been treated with stereotactic radiosurgery must be clinically stable for 1 month after treatment for the patient to be eligible. Patients with surg"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma
Udai Kammula 2018. "Adoptive Transfer of Tumor Infiltrating Lymphocytes for Metastatic Uveal Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03467516.
~16 spots leftby Apr 2027
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