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CAR T-cell Therapy

TIL Therapy for Pediatric Cancer

Phase 1

Waitlist Available

Led By Jonathan Metts, MD

Research Sponsored by Johns Hopkins All Children's Hospital

Eligibility Criteria Checklist

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

Must have

Patients must have an open surgical biopsy or resection planned (core needle/final needle biopsies are not allowed) for standard of care purposes, at some point in their initial or relapsed therapy for pMST.

Relapsed/refractory disease: Patients with a histologic diagnosis of high-risk pMST as defined in Part 1 inclusion who have recurrent/refractory local or metastatic disease that is either measurable or evaluable by RECIST 1.1.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial studies a cancer therapy with TILs to help pediatric patients with high-risk solid tumors.

Who is the study for?

This trial is for children and young adults aged 1 to 21 with high-risk solid tumors outside the brain. They must have recovered from previous cancer treatments, meet organ function requirements, and not be pregnant or nursing. Participants need a Karnofsky/Lansky score of at least 60%, no active infections requiring IV antibiotics, no CNS metastases history, and cannot be on other cancer therapies.Check my eligibility

What is being tested?

The study has two parts: first to see if it's possible to make TIL (Tumor-Infiltrating Lymphocyte) products from pediatric tumors; second to test the safety of TIL therapy combined with lymphodepleting chemo drugs Fludarabine and Cyclophosphamide followed by Interleukin-2 in these patients.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as fever or fatigue, chemotherapy-related effects like nausea or low blood counts leading to increased infection risk, and potential complications from Interleukin-2 which may affect heart or lung function.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for an open surgical biopsy or resection for my tumor.

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My high-risk cancer has come back or didn't respond to treatment and can be measured.

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My blood counts are within the required range for the trial.

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My kidney function is within the normal range for my age and sex.

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My lung function tests are above 50% of what's expected, or my oxygen levels are above 92% without extra oxygen.

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It's been over 21 days since my last antibody treatment and any side effects are mild.

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I have a high-risk pediatric cancer outside the brain with a low chance of being event-free in 5 years.

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My liver tests are within the required range.

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My heart is strong enough for the trial, based on recent tests.

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I am between 1 and 21 years old.

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I weigh at least 5 kg.

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It has been over 42 days since my last cellular therapy treatment.

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I can care for myself but may need occasional help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Safety of TIL therapy in Pediatric Solid Tumors

Secondary outcome measures

Disease Response to TIL Therapy

Feasibility of Generating TIL Product from Pediatric Solid Tumors

Toxicity of TIL Therapy in Pediatric Solid Tumors

Trial Design

1Treatment groups

Experimental Treatment

Group I: TIL TherapyExperimental Treatment1 Intervention

TIL therapy with lymphodepleting chemotherapy and Interleukin 2

0 / 13Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cannonball Kids Cancer FoundationUNKNOWN

Benjamin Gilkey FundUNKNOWN

Swim Across America FoundationUNKNOWN

Frequently Asked Questions

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

Are participants who are 25 years of age or older eligible for this experiment?

"This clinical study is open to participants aged one year to twenty-one. Its inclusion criteria stipulate that there are 320 trials for minors and 2350 for seniors."

Answered by AI

Would I satisfy the qualifications for participation in this medical trial?

"This research study is currently recruiting 30 patients aged 1 to 21 years old, who have lymphocytes and a diagnosis of pMST that has failed standard initial therapy."

Answered by AI

Has the FDA given its stamp of approval to TIL Therapy?

"Our researchers at Power give TIL Therapy a low safety score of 1 due to the fact that this is an early Phase 1 trial, meaning there are only small amounts of data available on both efficacy and risk."

Answered by AI

Is this clinical trial still recruiting participants?

"Clinicaltrials.gov records confirm that this trial, which was initially advertised on December 1st 2023, is no longer recruiting candidates. Fortunately, there are still 2544 other medical trials open for enrollment presently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

2024. "Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06047977.