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CAR T-cell Therapy

Adoptive Cellular Therapy for Brain Cancer (PEACH Trial)

Phase 1

Recruiting

Research Sponsored by Giselle SaulnierSholler

Eligibility Criteria Checklist

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

Must have

Neuroblastoma patients must be age >12 months at enrollment

Subjects must have proven pediatric cancer with confirmation at diagnosis or at the time of recurrence/progression and clinical determination of disease for which there is no known effective curative therapy or disease that is refractory to established proven therapies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

PEACH Trial Summary

This trial is testing a new cancer treatment that uses molecular targeted therapy in combination with adoptive cell therapy. The goal is to find the maximum tolerated dose and to evaluate the safety and feasibility of this new treatment.

Who is the study for?

This trial is for children with specific pediatric cancers like high-risk neuroblastoma or brain stem gliomas, who have no known effective curative therapy available. Participants must be aged ≤ 30 years, have a certain level of physical functioning (Lansky/Karnofsky Score ≥ 60), and agree to use effective birth control. They should not have significant organ dysfunction or other serious medical conditions that could affect the study.Check my eligibility

What is being tested?

The PEACH TRIAL tests a combination of molecular targeted therapy with adoptive cell therapy in children with newly diagnosed DIPG or recurrent neuroblastoma. It aims to find the safest dose for treatments involving autologous dendritic cells, lymphocyte transfer, and hematopoietic stem cells.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever and fatigue, complications from biopsies like bleeding or infection, and typical risks associated with cellular therapies which can range from mild flu-like symptoms to more severe immune responses.

PEACH Trial Eligibility Criteria

Inclusion Criteria

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

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I am over 12 months old with neuroblastoma.

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My child's cancer cannot be cured with known treatments or has not responded to standard therapies.

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I am 30 years old or younger.

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My cancer can be measured and is reachable for a biopsy.

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I am 3 years old or older with Diffuse Intrinsic Pontine Glioma.

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My blood counts and kidney function are within normal ranges.

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My condition has no known effective treatment.

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My condition is either high-risk neuroblastoma or a type of brain stem cancer.

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I can care for myself but may need occasional help.

PEACH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 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

Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability

Secondary outcome measures

Determine the Overall Response Rate (ORR) of Participants using INSS Response Evaluation Criteria for NB and RANO criteria for DIPG

Number of Participants that are able to have vaccine produced and delivered

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

+2 more

PEACH Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: Relapsed/Refractory Neuroblastoma (NB)Experimental Treatment1 Intervention

This Phase I study is will utilize a standard 3+3 dose escalation design to establish the MTD and will evaluate the following three pre-specified dose levels of xALT: Dose Level 1: 3 x10^7 cells/kg Dose Level +1: 3 x10^8 cells/kg Dose Level -1: 3 x10^6 cells/kg The dose escalation scheme will be evaluated for Arm 1 and Arm 2 separately. For each Study Arm, a minimum of 4 DLT evaluable subjects and a maximum of 12 DLT evaluable subjects will be enrolled (a total of 8 to 24 DLT evaluable subjects).

Group II: Arm 1: Subjects with Diffuse Intrinsic Pontine Glioma (DIPG).Experimental Treatment1 Intervention

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beat Childhood Cancer Research ConsortiumUNKNOWN

Giselle SaulnierShollerLead Sponsor

21 Previous Clinical Trials

2,194 Total Patients Enrolled

Giselle ShollerLead Sponsor

21 Previous Clinical Trials

2,181 Total Patients Enrolled

Media Library

TTRNA-xALT (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04837547 — Phase 1

$Diffuse Intrinsic Pontine Glioma Research Study Groups: Arm 2: Relapsed/Refractory Neuroblastoma (NB), Arm 1: Subjects with Diffuse Intrinsic Pontine Glioma (DIPG).$

Diffuse Intrinsic Pontine Glioma Clinical Trial 2023: TTRNA-xALT Highlights & Side Effects. Trial Name: NCT04837547 — Phase 1

TTRNA-xALT (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04837547 — Phase 1

Frequently Asked Questions

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

Could you provide insight on the potential risks of Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) to participants?

"Based on the available data, our team at Power has assigned a score of 1 out of 3 to TTRNA-xALT's safety due to it being in Phase 1 - meaning there is limited information regarding its efficacy and security."

Answered by AI

Will I qualify to join the research project?

"This clinical trial is set to welcome 24 individuals aged 1 year and 30 with neuroblastoma into the study. Furthermore, participants must have measurable disease as defined in section 8 of this research, a tumor sample containing over 30% viable tissue for analysis, not be more than two months past diagnosis or beginning radiation therapy, relapsed after standard care treatments or showing non-responsiveness/progression from accepted curative chemotherapy regimens if applicable, possess diffuse intrinsic pontine gliomas (or another brain stem affliction), and finally have their age at enrollment capped at thirty years old; should all criteria be met then the patient and/or"

Answered by AI

How many test subjects are enrolled in this investigation?

"Correct. The clinicaltrials.gov website verifies that this medical study, which was originally published on September 20th 2021, is currently enrolling people in the trial. Specifically, 24 patients need to be recruited from 2 different locations for participation."

Answered by AI

Is enrollment for this research endeavor still available?

"Affirmative. Clinicaltrials.gov data reveals that this experiment, first published on September 20th 2021, is presently enrolling participants. There are 24 openings at two distinct medical centres as of April 2022."

Answered by AI