Tumor-infiltrating lymphocyte treatment for anti-PD-1-resistant metastatic lung cancer: a phase 1 trial.
Benjamin C Creelan, Chao Wang, Jamie K Teer...
https://pubmed.ncbi.nlm.nih.gov/34385708Actively Recruiting
Phase 1
Age: 18Years +
All Genders
ID05681780
Clinical Trial of CD40L-augmented Tumor Infiltrating Lymphocytes (CD40L TIL) for Patients With Oncogene-Driven Advanced Non-Small Cell Lung Cancer (NSCLC)
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-03-31
20
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a special preparation of immune cells called tumor-infiltrating lymphocytes (TIL) that are stimulated with CD40L. These cells are given together with the drug nivolumab to patients who have advanced non-small cell lung cancer (NSCLC) with specific genetic changes in EGFR, ALK, ROS1, or HER2. This phase 1 clinical trial aims to explore how this combination works for these patients whose cancer has progressed after previous treatments. Participants will receive an infusion of nivolumab every three weeks before receiving chemotherapy with cyclophosphamide and fludarabine to prepare the body for TIL therapy. On day 0, they will be given an infusion of the prepared TIL cells followed by up to six doses of interleukin-2 (IL-2) to support the immune response. Afterward, nivolumab infusions continue every four weeks for up to 12 months. The study focuses on this combined treatment approach and its administration schedule. During the study, participants will be closely monitored for side effects up to 18 months. Researchers will also assess how the cancer responds to treatment, the duration of any response, and overall survival for up to five years. The study involves tumor sampling to grow TIL cells, blood tests, physical exams, imaging scans, and other assessments to track health and treatment effects. The total participation time will vary, with ongoing follow-up to evaluate long-term outcomes and safety.
CONDITIONS
Brief Title
Clinical Trial of CD40L-Augmented TIL for Patients With EGFR, ALK, ROS1 or HER2-Driven NSCLC
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age greater than or equal to 18 years
- Diagnosis of stage IV or recurrent non-small cell lung cancer with activating genomic alterations in EGFR, ALK, ROS1, or ERBB2
- ECOG performance status of 0 or 1
- Expected survival of 4 months or more
- Disease progression after at least one prior systemic therapy including targeted therapies when applicable
- Measurable disease excluding the lesion used for TIL harvest
- Tumor accessible for biopsy expected to yield at least 1.5 cm3 of tissue
- Brain metastases allowed if stable or treated appropriately
- Adequate organ and marrow function as defined by lab criteria
- Pulmonary function tests showing DLCO of 45% or more
- HIV-infected participants must be stable on antiretroviral therapy with undetectable viral load
- Participants with chronic hepatitis B or C must have controlled or cured infection
- Prior or concurrent malignancies allowed if not interfering with study safety or efficacy
You will not qualify if you...
- More than six prior systemic therapies for NSCLC
- Prior PD-1 or PD-L1 inhibitor treatment for metastatic NSCLC
- Rapidly progressing tumors
- Active or recent autoimmune diseases within 2 years except some exceptions with approval
- Active leptomeningeal or pachymeningeal metastases or carcinomatous meningitis
- Primary immunodeficiency or recent immunosuppressive therapy
- Chronic steroid use above allowed doses
- Uncontrolled illnesses including serious heart conditions
- Unresolved significant toxicity from prior treatments
- Prolonged QTc interval over 480 ms
- Active systemic infections needing IV antibiotics recently
- History of organ transplant
- Psychiatric or social issues limiting study compliance
- History of anaphylaxis to beta-lactam antibiotics without evaluation and clearance
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - Approximately 3 weeks
Participants receive nivolumab infusions every 3 weeks prior to lymphodepletion chemotherapy.
1 to 2 visits (in-person) before chemotherapy
Treatment
Duration - Approximately 2 weeks
Participants undergo lymphodepletion chemotherapy with cyclophosphamide and fludarabine, followed by tumor-infiltrating lymphocytes (TIL) infusion and interleukin-2 (IL-2) therapy.
Multiple visits including chemotherapy days and TIL infusion (in-person)
Treatment
Duration - Up to 12 months
After TIL infusion, participants receive nivolumab infusions every 4 weeks for up to 12 months.
Monthly visits for nivolumab infusions
Follow-up
Duration - Up to 5 years
Participants are monitored for safety and treatment outcomes including adverse events and survival.
Periodic follow-up visits
Trial Site Locations
Total: 1 location
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
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Research Team
B
Ben Creelan
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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