PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT04837547
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) — BIOLOGICAL
    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 Details

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)).

Key Dates

Start date
Sep 20, 2021
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2032

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Subjects with Diffuse Intrinsic Pontine Glioma (DIPG).
    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).
  • Experimental: Arm 2: Relapsed/Refractory Neuroblastoma (NB)
    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).

Primary Outcome Measure

Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability [ Time Frame: 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611
Marcia Hodik, RN
[email protected]
352-273-9050
John Ligon, MD (PRINCIPAL_INVESTIGATOR)
Levine Children's HospitalCharlotteNorth Carolina28204-
Penn State Milton S. Hershey Medical Center and Children's HospitalHersheyPennsylvania17033
Penn State Clinical Trials
[email protected]
Valerie Brown, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Gainesville, FL

By condition
Neuroblastoma
By specialty
OncologyPediatric oncology
By research site
University of Florida· Gainesville, FLLevine Children's Hospital· Charlotte, NCPenn State Milton S. Hershey Medical Center and Children's Hospital· Hershey, PA

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