← Back to Search

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

Must not have

Absence of tumor on biopsy specimen or a diagnosis other than NBL or glioma on biopsy

Subjects who have received any cytotoxic chemotherapy within the last 7 days prior to biopsy or focal radiotherapy in the case of patients with diffuse intrinsic pontine (or other brain stem) gliomas

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am over 12 months old with neuroblastoma.

Select...

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

Select...

I am 30 years old or younger.

Select...

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

Select...

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

Select...

My blood counts and kidney function are within normal ranges.

Select...

My condition has no known effective treatment.

Select...

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

Select...

I can care for myself but may need occasional help.

Exclusion Criteria

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

Select...

My biopsy did not show cancer or showed a type other than neuroblastoma or glioma.

Select...

I haven't had chemotherapy or specific brain cancer radiation in the last week.

Select...

I have an autoimmune disease, immunosuppression, or HIV.

Select...

I have major issues with my kidneys, heart, lungs, liver, or other organs.

Select...

I do not have any serious infections or life-threatening illnesses unrelated to my cancer.

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

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

Primary study objectives

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

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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 / 14Eligibility criteria met