PEACH TRIAL: Precision Medicine and Adoptive Cellular Therapy for Neuroblastoma and DIPG

This study is testing a new treatment for children and young adults (ages 1 to 30) with high-risk neuroblastoma or diffuse intrinsic pontine glioma (DIPG), which are types of pediatric cancer. The treatment involves using your own immune cells, specifically a product called TTRNA-xALT (tumor-specific ex vivo expanded autologous lymphocyte transfer), which is a type of targeted therapy. Researchers want to see how safe this treatment is and how well people tolerate it over two years. This trial is for patients whose cancer has not responded to other treatments or for whom there is no known cure. The goal is to find the highest safe dose of this new therapy.

Study design: This is an open-label, multicenter study, meaning both you and the study team will know which treatment you are receiving. It plans to enroll 24 participants to evaluate the safety and feasibility of the treatment.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The study will measure safety and tolerability for up to 2 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy

Recruiting

PHASE1Ages 1–30InterventionalTreatment

University of Florida

~24 participants

Updated 2026-07-01 on ClinicalTrials.gov

What's tested:Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)

At a glance

Recruiting sites

2 of 3 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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

Measured over 2 years

Conditions

Neuroblastoma

Diffuse Intrinsic Pontine Glioma

NCT04837547

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Penn State Milton S. Hershey Medical Center and Children's Hospital
Hershey, Pennsylvaniastudy coordinator listed
Recruiting
University of Florida
Gainesville, Floridastudy coordinator listed
Recruiting
Levine Children's Hospital
Charlotte, North Carolinano site contact published
Active, not recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

Giselle Sholler, MD · STUDY_CHAIR · Beat Childhood Cancer at Penn State University
Duane Mitchell, M.D., Ph.D. · STUDY_CHAIR · University of Florida

Who to contact

BCC Enroll

[email protected]

717-531-0003

Email the study team

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Eligibility criteria

Inclusion

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 fitting into one of the following categories:

Disease Status:

All subjects must be age ≤ 30 years at enrollment

Patient and/or parents/guardian willing to consent to biopsy for obtaining tumor material for confirmatory diagnosis and/or tumor RNA extraction and amplification.

Subjects must have measurable disease as defined Per section 8 at the time of biopsy and tumor or bone marrow must be accessible for biopsy. Tumor or bone marrow samples submitted for analysis must contain \>20% viable tumor tissue to qualify. Note: Subjects with NB who are expected to have no evidence of disease after surgical removal of their tumor are still eligible for this trial if their disease would normally require adjuvant chemotherapy treatment after surgery despite NED status.

Current disease state must be one for which there is currently no known effective therapy

Specimens will be obtained only in a non-significant risk manner and not solely for the purpose of investigational testing.

Lansky or Karnofsky Score must be ≥ 60

Bone Marrow:

Renal: Serum creatinine ≤ upper limit of institutional normal.

Adequate liver function must be demonstrated, defined as:

Subjects with CNS disease currently taking steroids must have been on a stable dose of steroids for at least one week prior to their biopsy and must not have progressive hydrocephalus at enrollment.

A negative serum pregnancy test is required for female participants of childbearing potential (≥13 years of age or after onset of menses)

Both male and female post-pubertal study subjects need to agree to use one of the more effective birth control methods during treatment and for six months after treatment is stopped. These methods include total abstinence (no sex), oral contraceptives ("the pill"), an intrauterine device (IUD), levonorgestrel implants (Norplant), or medroxyprogesterone acetate injections (Depo-provera shots). If one of these cannot be used, contraceptive foam with a condom is recommended.

Informed Consent: All subjects and/or legal guardians must sign informed written consent. Assent, when appropriate, will be obtained according to institutional guidelines

Post-Biopsy: Patients with post-biopsy neurological deficits should have deficits that are stable for a minimum of 1 week prior to registration.

Exclusion

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

Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection.

Subjects with significant renal, cardiac, pulmonary, hepatic or other organ dysfunction.

Prior allergic reaction to GM-CSF or Td.

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

Subjects with NBL who have received any radiotherapy to the primary sample site within the last 14 days (radiation may be included in treatment decision after biopsy).

Subjects receiving any investigational drug concurrently.

Subjects with uncontrolled serious infections or a life-threatening illness (unrelated to tumor)

Subjects with any other medical condition, including malabsorption syndromes, mental illness or substance abuse, deemed by the Investigator to be likely to interfere with the interpretation of the results or which would interfere with a subject's ability to sign or the legal guardian's ability to sign the informed consent, and subject's ability to cooperate and participate in the study

What this trial measures

Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability2 years
To evaluate the dose-limiting toxicities (DLTs) and to establish the maximum tolerated dose (MTD) of treating children with molecular targeted therapy in combination with adoptive cellular therapy

Trialytics