Tumor Infiltrating Lymphocyte Therapy for Pediatric High Risk Solid Tumors

NCT06047977 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: MCC-23265IRB00486298
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lymphocytes

Outcome Measures

Primary Outcomes (1)

• Safety of TIL therapy in Pediatric Solid Tumors

  The regimen will be declared safe if \<33% of patients (0 or 1 out of maximum 6 patients on the safety phase) experience a dose-limiting toxicity (DLT).

  3 years

Secondary Outcomes (3)

• Feasibility of Generating TIL Product from Pediatric Solid Tumors

  3 years

• Toxicity of TIL Therapy in Pediatric Solid Tumors

  3 years

• Disease Response to TIL Therapy

  3 years

Study Arms (1)

TIL Therapy

EXPERIMENTAL

TIL therapy with lymphodepleting chemotherapy and Interleukin 2

Biological: Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2

Interventions

Tumor Infiltrating Lymphocytes, Fludarabine, Cyclophosphamide, Interleukin-2 BIOLOGICAL

Lymphodepleting Chemotherapy with Fludarabine/Cyclophosphamide followed by TIL and Post-TIL Interleukin-2 (IL-2)

TIL Therapy

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Swim Across America: collaborator
• Benjamin Gilkey Fund: collaborator
• Cannonball Kids' Cancer Foundation: collaborator

Study Sites (1)

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, 33701, United States

RECRUITING

MeSH Terms

Interventions

fludarabine; Cyclophosphamide; Interleukin-2

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors

Study Officials

• Jonathan Metts, MD

  Moffitt Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jade Hanson

CONTACT

727-767-6468; Jade.Hanson@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: June 2, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)