Actively Recruiting
Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2025-07-16
30
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
S
Swim Across America
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 1 to 21 years at enrollment in Part One
- Diagnosis of high-risk pediatric malignant solid tumors outside the central nervous system, newly diagnosed or under initial therapy with expected 5-year event-free survival less than 60%
- Includes specific tumor types such as high-risk neuroblastoma, metastatic Ewing sarcoma, metastatic osteosarcoma, hepatoblastoma not amenable to resection, desmoplastic small round cell tumor, metastatic rhabdomyosarcoma, metastatic non-rhabdomyosarcoma soft tissue sarcomas, metastatic diffuse anaplastic Wilms tumor, malignant rhabdoid tumor of kidney or liver, mediastinal mixed germ cell tumors, or other tumors as approved
- Patients with relapsed, refractory, or recurrent pediatric malignant solid tumors
- Planned open surgical biopsy or resection for standard care during initial or relapsed therapy
- Ability and willingness to provide written informed consent or assent
- For Part Two: age 1 year or older at enrollment, weight at least 5 kg, Karnofsky/Lansky score 60% or higher
- Confirmation of adequate TIL cellular product availability
- Disease status: relapsed/refractory measurable or evaluable disease OR adjuvant therapy for poor prognosis tumors with stable disease or better
- Adequate hematologic, liver, renal, cardiac, and pulmonary function as specified
- Appropriate recovery time from prior therapies as detailed in the protocol
You will not qualify if you...
- For Part Two: active systemic infections requiring intravenous antibiotics
- Positive tests for HIV, hepatitis B, human T-cell leukemia-lymphoma virus (HTLV) I or II, syphilis, or detectable hepatitis C viral load
- Pregnant or nursing patients
- Patients requiring chronic immunosuppressive systemic steroids or immunosuppressive medications for autoimmune diseases
- Patients with current or past central nervous system metastases
- History of prior solid organ transplant
- Inability to understand or provide informed consent
- Receiving other anti-cancer or investigational therapies concurrently
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701
Actively Recruiting
Research Team
J
Jade Hanson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here