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CAR T-cell Therapy

Adoptive Cellular Therapy for Pediatric Brain Tumors (IMPACT Trial)

Phase 1

Recruiting

Led By Brian Rood, MD

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

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

Must have

Organ function: ANC ≥750/µL, Absolute lymphocyte count (ALC) >500/μL, Platelets ≥75K, Bilirubin ≤3xULN, Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) <5x upper limit of normal (ULN), Serum creatinine ≤1.0mg/dL or 1.5x ULN for age (whichever is higher), Pulse oximetry >90% on room air

Parent(s)/guardian(s) capable of providing informed consent

Must not have

Patients with uncontrolled infections

Patients with medulloblastoma of the SHH subtype

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial is testing a new treatment for young children with brain tumors who cannot undergo radiation therapy. The treatment involves using the patient's own immune cells to target specific proteins found in the tumor. The study

Who is the study for?

This trial is for children under 5 with certain brain tumors (like medulloblastoma, pineoblastoma) who can have a device called an Ommaya reservoir placed in their brain. They should be able to handle the procedure to collect blood cells and have enough tumor tissue available. Their body must be functioning well overall, with acceptable blood counts and organ function.

What is being tested?

The IMPACT study tests personalized immune cells (TSA-T) designed to target specific proteins on a child's own brain tumor. It's after standard treatments like chemo. The goal is to see if these custom-made cells are safe and how they affect the tumor and the child's immune system.

What are the potential side effects?

Potential side effects aren't specified here but generally, therapies using T-cells could cause reactions at infusion sites, flu-like symptoms, changes in blood pressure or heart rate, allergic reactions, or more serious immune responses affecting different organs.

Eligibility Criteria

Inclusion Criteria

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

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My parent or guardian can give consent for me.

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I have been newly diagnosed with a specific type of brain tumor.

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I am under 5 years old.

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I can do most activities but may need help.

Exclusion Criteria

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

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I do not have any infections that aren't responding to treatment.

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My medulloblastoma is of the SHH subtype.

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I am taking more than 0.05mg/kg of dexamethasone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Any unexpected toxicity of grade ≥3 attributed to the infusion of TSA-T

Grade ≥3 infusion-related adverse event

Grade ≥3 pneumonitis, uveitis

+2 more

Secondary study objectives

Overall survival

Progression free survival

TSA-T responses

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: Embryonal brain tumorsExperimental Treatment1 Intervention

These patients are young children (\<5 years of age) with newly diagnosed high-risk embryonal CNS malignancies and are expected to have a modest male predominance reflecting the sex-based incidence of pediatric brain tumors. Patients will have a Lansky performance status of ≥60.

0 / 8Eligibility criteria met