Actively Recruiting
A Phase I Study to Assess Safety and Tolerability of Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte Therapy in Advanced Epithelial and Immune Checkpoint Blockade Resistant Solid Tumors
Led by Vall d'Hebron Institute of Oncology · Updated on 2024-11-07
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Vall d'Hebron Institute of Oncology
Lead Sponsor
B
Banc de Sang i Teixits
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a new type of cancer treatment called NEXTGEN-TIL, which uses specially selected immune cells called tumor-infiltrating lymphocytes (TILs) taken from a patient's own tumor. This early phase trial focuses on patients with metastatic or unresectable epithelial cancers and solid tumors that have not responded to immune checkpoint blockade therapies. The goal is to evaluate the safety and tolerability of this next-generation TIL therapy, as well as to explore its early effects on cancer in these patients. The treatment involves collecting TILs from the patient's tumor and growing them in the lab to enhance their cancer-fighting ability. Before receiving the TIL infusion, patients undergo a preparative chemotherapy regimen called non-myeloablative lymphodepletion to help the infused cells expand. After the TIL therapy, patients receive injections of interleukin-2 (IL-2) to support the immune cells. The TIL infusion is given intravenously on Day 0, following chemotherapy, and IL-2 is administered multiple times over the next few days. Patients are then followed for up to 2 years with regular assessments. Participants will have frequent visits during the first 9 months and additional check-ins up to 2 years to monitor treatment safety and effects. Researchers will collect data on adverse events, laboratory tests, heart function, vital signs, physical exams, and performance status. They will also study the characteristics of the infused TILs and measure cancer response and progression over time. This thorough monitoring helps ensure patient safety and gathers information on how well the therapy works.
CONDITIONS
Brief Title
Assessment of the Safety and Tolerability of ex Vivo Next-generation Neoantigen-selected Tumor-infiltrating Lymphocyte (TIL) Therapy in Advanced Epithelial Tumors and Immune Checkpoint Blockade (ICB) Resistant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed metastatic or unresectable solid tumors
- Disease progressed after at least one standard therapy, including immune checkpoint blockade if approved
- At least one lesion suitable for biopsy or resection with minimal risk
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Medically fit to undergo study procedures and treatment
- Left ventricular ejection fraction (LVEF) of 45% or higher
- Pulmonary function tests (FEV1, FVC, DLCO) of 50% or higher
- Seronegative for HIV, active hepatitis B and hepatitis C
- Life expectancy of 6 months or more
- Agreement to use effective contraception if of childbearing potential during and 6 months after treatment
- Adequate blood counts and organ function as defined by study requirements
- Recovery from prior therapy toxicities to Grade 1 or less (with some exceptions)
You will not qualify if you...
- Untreated or symptomatic brain metastases
- Leptomeningeal carcinomatosis
- Active invasive malignancies within 3 years, except certain skin, cervical, bladder, breast, or prostate cancers
- Active systemic infections requiring treatment
- Active hepatitis B or C infections
- Active autoimmune diseases requiring immunosuppressive therapy
- History of organ or bone marrow transplant
- Primary immunodeficiency disorders
- Regular steroid use above prednisone 10 mg/day
- Significant uncontrolled cardiac, pulmonary, hepatic, renal, hematological, endocrine, gastrointestinal or neurological diseases
- History of coronary revascularization or ischemic symptoms
- Idiopathic pulmonary fibrosis or active pneumonitis
- Allergies to treatment compounds
- Contraindications to cyclophosphamide, fludarabine, or IL-2
- Recent anti-cancer therapies or vaccinations within defined timeframes
- Major surgery within 3 weeks before lymphodepleting therapy
- Prior investigational cell or gene therapies
- Pregnant or breastfeeding women of childbearing potential
- Any condition that may impair compliance with study protocol or follow-up schedule
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 days
Participants receive a preparative non-myeloablative lymphodepleting chemotherapy regimen consisting of Cyclophosphamide and Fludarabine prior to the experimental treatment.
Daily visits for 5 days
Duration - 3 days
Participants receive a single dose of the NEXTGEN-TIL cellular therapy followed by sequential doses of IL-2 infusion depending on tolerance to support the treatment.
1 infusion visit followed by up to 3 additional visits for IL-2 dosing
Duration - Up to 2 years
Participants are monitored for safety, tolerability, and treatment response with scheduled assessments up to 2 years after treatment.
Visits at weeks 2, 3, 4, 6, 9, 12, 18, 24, 30, 36, and at 1 year, 1.5 years, and 2 years
Trial Site Locations
Total: 1 location
1
Vall d'Hebron Institute of Oncology
Barcelona, Spain
Actively Recruiting
Research Team
E
Elena Garralda
S
Susana Muñoz
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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