Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

Part of paid clinical trials in St. Petersburg, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06047977
Phase
PHASE1
Status
Recruiting
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Conditions

  • Lymphocytes

Eligibility Criteria

Sex
ALL
Age
1 Year - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2 — BIOLOGICAL
    Lymphodepleting Chemotherapy with Fludarabine/Cyclophosphamide followed by TIL and Post-TIL Interleukin-2 (IL-2)

Study Details

Part One of this study will determine the feasibility of creating Tumor-Infiltrating Lymphocyte (TIL) product prospectively from high-risk pediatric solid tumors. Part Two of this study will determine the safety of TIL therapy with lymphodepleting chemotherapy and post-TIL Interleukin-2 in high-risk pediatric solid tumors

Key Dates

Start date
Jun 2, 2025
Status verified
Jul 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TIL Therapy
    TIL therapy with lymphodepleting chemotherapy and Interleukin 2

Primary Outcome Measure

Safety of TIL therapy in Pediatric Solid Tumors [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins All Children's HospitalSt. PetersburgFlorida33701
Jade Hanson
[email protected]
727-767-6468
Muaz Alrazzak, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Johns Hopkins All Children's Hospital· St. Petersburg, FL