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NeuroblastomaPhase 1PEACHNCT04837547

PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy

A Phase 1 study testing Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) in people with Neuroblastoma and Diffuse Intrinsic Pontine Glioma, run by University of Florida at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

A Phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy (Total tumor mRNA-pulsed autologous Dendritic Cells (DCs)… Read more about this study

Who is it for?
Ages 1 year to 30 years
What is being tested?
Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
3 sitesUnited States
Study dates
20 Sep 2021to Sep 2032
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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:
  • High Risk Neuroblastoma-
  • Patients that have relapsed following standard of care therapy or having progressed during standard of care therapy and non-responsive/progressive to accepted curative chemotherapy.
  • Neuroblastoma must be age >12 months at enrollment
  • Diffuse Intrinsic Pontine (or other brain stem) Glioma
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  • Newly-diagnosed patients willing to undergo biopsy
  • Must be within 2 months of diagnosis and prior to starting radiation
  • DIPG must be ≥ 3 years of age at enrollment
  • 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:
  • ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported- >24 hrs off G-CSF and 7 days off neulasta)
  • Platelets ≥ 100,000/µl (can be transfused)
  • Hemoglobin > 8 g/dL (can be transfused)
  • Renal: Serum creatinine ≤ upper limit of institutional normal.
  • Adequate liver function must be demonstrated, defined as:
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age AND
  • ALT (SGPT) ≤ 3 times upper limit of normal (ULN) for age
  • AST (SGOT) ≤ 3 times upper limit of normal (ULN) for age.
  • 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.

Who cannot join

  • 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).
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  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Levine Children's Hospital

    Charlotte, North Carolina, 28204

  • University of Florida

    Gainesville, Florida, 32611

  • Penn State Milton S. Hershey Medical Center and Children's Hospital

    Hershey, Pennsylvania, 17033

Other trials in United States

About this study

Official title: PEACH TRIAL- Precision mEdicine and Adoptive Cellular tHerapy for the Treatment of Recurrent Neuroblastoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)

A Phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy (Total tumor mRNA-pulsed autologous Dendritic Cells (DCs) (TTRNA-DCs), Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) and Autologous G-CSF mobilized Hematopoietic Stem Cells (HSCs)).

Being tested
Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)
Medical subject headings
Neuroblastoma, Diffuse Intrinsic Pontine Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)Biological

    Also called xALT

    There will be two immunotherapy products manufactured and administered to subjects enrolled on this trial. The first product will be autologous dendritic cells (DCs) loaded with total tumor messenger ribonucleic acid (mRNA) (TTRNA) derived from malignant tumors. The second product will be autologous T lymphocytes stimulated ex vivo against TTRNA antigens for autologous transfer (TTRNA-xALT). DCs are professional antigen-presenting cells critical for the initiation of B and T-cell responses in vivo.

Study groups in NCT04837547
Study groupRoleWhat they receive
Arm 1: Subjects with Diffuse Intrinsic Pontine Glioma (DIPG).ExperimentalThis 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).
Receives: Biological: Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)
Arm 2: Relapsed/Refractory Neuroblastoma (NB)ExperimentalThis 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).
Receives: Biological: Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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

    Measured: 2 years

Secondary outcomes (5)

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

    To evaluate the overall safety profile of study treatment

    Measured: 2 years plus 30 days

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

    To evaluable the feasibility of producing and administering the protocol directed therapy

    Measured: 2 years

  3. Number of participants with progression free survival (PFS) during study

    To determine the activity of treatments chosen based on Progression free survival (PFS)

    Measured: 7 years

  4. Number of participants with overall survival (OS) during study

    To determine the activity of treatments chosen based on Overall Survival (OS)

    Measured: 7 years

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

    To determine the activity of treatments chosen based on Overall Response Rate (ORR)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start20 Sep 2021
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04837547
Sponsor's protocol ID
BCC017
Acronym
PEACH
Status last verified
Sep 2026
First submitted
6 Apr 2021
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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