Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

Recruiting now · Phase 1

Conditions studied: Lymphocytes

In brief

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 facts

Study ID

NCT06047977

Run by

H. Lee Moffitt Cancer Center and Research Institute

People needed

30

Starts

2025-06-02

Expected to finish

2027-12-01

Last updated by the study team

2025-07-16

Who can join

Age: 1 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Part One (Prospective biobanking study):
• Patients must be ≥1 year to ≤ 21 years of age at time of enrollment to Part One.
• Initial therapy patients: Patients with a histologic diagnosis of high-risk pediatric malignant solid tumors (pMST), defined as a pediatric malignant solid tumor outside of the central nervous system, newly-diagnosed or being treated with initial therapy, with expected 5-year Event-Free Survival (EFS) <60%. Examples include:
• High-risk neuroblastoma
• Metastatic Ewing sarcoma
• Metastatic osteosarcoma
• Hepatoblastoma metastatic or not amenable to total resection
• Desmoplastic small round cell tumor
• Metastatic rhabdomyosarcoma
• Metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS)
• Metastatic diffuse anaplastic Wilms tumor
• Malignant rhabdoid tumor of kidney or liver
• Mediastinal mixed germ cell tumors
• Other tumors may be deemed eligible after assessment and documentation of prognosis from an enrolling institution's multidisciplinary tumor board.
• Note: There will be occasions prior to establishment of a histologic diagnosis where an investigator will highly suspect one of the diagnoses above in a patient due to undergo a surgical procedure (initial biopsy, up-front resection, etc.). If this is the case, the investigator may choose to enroll the patient prior to a tissue diagnosis. Their suspicion of a qualifying diagnosis should be documented. If the diagnosis is confirmed, the patient may continue on study. If the diagnosis is not confirmed, the patient will be considered a screening failure and removed from study.
• Relapsed/refractory/recurrent patients: patients must have a histologic diagnosis of pMST (may include diagnoses outside those identified in Part 1) that has relapsed after achieving remission or progressed after completion of all planned initial therapy.
• Patients must have an open surgical biopsy or resection planned (core needle/final needle biopsies are not allowed) for standard of care purposes, at some point in their initial or relapsed therapy for pMST.
• Note: The surgery for tissue procurement may occur at any time during initial therapy including up-front surgeries or after neoadjuvant therapies, including chemotherapy, immunotherapy, and radiation.
• All patients and/or their parents or legal guardians must have the ability to understand and the willingness to sign a written informed consent or assent document.
• Part Two: Phase I Clinical Trial
• ≥1-year-old at enrollment. There is no upper bound age limit, as long as the patient met age criteria at the time of enrollment on Part One.
• Weight ≥ 5 kg at time of enrollment for Part Two.
• Written informed consent from patient/family (separate from Part One).
• Confirmation of satisfactory TIL cellular product availability.
• Karnofsky/Lansky (as age appropriate) score ≥60%.

You may not qualify if…

• Part One: There are no exclusion criteria
• Part Two:
• Patients with active systemic infections requiring intravenous antibiotics
• Patients testing positive for HIV titer, hepatitis B surface antigen, human T-cell leukemia-lymphoma virus (HTLV) I or II antibody, or both rapid plasma regain (RPR) and fluorescent treponemal antibody (FTA) are excluded. Patients with hepatitis C antibody must have a negative (undetectable) viral load by polymerase chain reaction (PCR).
• Patients who are pregnant or nursing.
• Sexually active patients of reproductive potential are eligible if they have agreed to use an effective contraceptive method from the time of informed consent through the duration and for 1 month following completion of protocol treatment. The definition of an effective contraceptive method will be at the discretion of the institutional investigator.
• Patients needing chronic immunosuppressive systemic steroids are excluded. Any supraphysiologic doses of steroids should be discontinued by the time of enrollment.
• Patients with autoimmune diseases that require immunosuppressive medications.
• Patients with central nervous system metastases, currently active or in the past.
• Patients with history of prior solid organ transplant.
• Inability to comprehend and give informed consent.
• Patients receiving concomitant anti-cancer therapies or investigational therapies.

Where it is running

• Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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