TIL Therapy Combined With Pembrolizumab for Advanced or Metastatic Refractory Lung Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age16-90
SponsorEssen Biotech
About this trial
This Phase I/II study evaluates the safety and efficacy of autologous tumor-infiltrating lymphocytes (TIL) therapy combined with Pembrolizumab (Keytruda) immunotherapy in patients with advanced or metastatic refractory lung cancer. Lifileucel (Amtagvi), the first FDA-approved TIL therapy, has demonstrated significant success in treating unresectable or metastatic melanoma by utilizing the patient's own immune cells to combat cancer. This study aims to apply a similar approach to lung cancer. TILs will be harvested from patients' tumors, expanded in vitro, and infused back into the patients following a non-myeloablative lymphodepletion regimen. Pembrolizumab, a monoclonal antibody targeting the PD-1 receptor on T cells, will be administered to enhance the immune response. The primary endpoint is to determine the objective response rate (ORR) of this combined therapy. Secondary endpoints include disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DOR), and quality of life (QoL). This trial aims to offer a novel, personalized treatment option for patients with limited therapeutic alternatives.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age: 16 years to 90 years
Histologically diagnosed as primary/relapsed/metastasized Lung cancer
Expected life span more than 3 months
Karnofsky≥60% or ECOG score 0-2
Disqualifiers
Need glucocorticoid treatment, and daily dose of Prednisone greater than 15mg (or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment
Forced expiratory volume in one second (FEV1) less than 2L, diffusing capacity of the lung for carbon monoxide (DLCO) (calibrated) less than 40%
New York Heart Association (NYHA) Grade III or IV congestive heart failure, clinically significant
Low blood pressure, uncontrollable symptomatic coronary artery diseases, or ejection fraction less than 35%; Severe cardiac rhythm and conduction anomaly, such as ventricular arrhythmia requiring clinical intervention, second-third degree atrioventricular conductive block, etc.
Trial design
Design model
Single group
Treatments tested in this trial
Tumor Infiltrating Lymphocytes (TIL)
Biological/VaccineTumor Infiltrating Lymphocytes (TIL) IV
Cyclophosphamide
DrugCyclophosphamide will be administered as an intravenous (IV) infusion for two days.
Fludarabine
DrugFludarabine will be administered as an intravenous (IV) infusion for five days.
Interleukin-2
DrugAfter TIL infusion, IL-2 will be started as a bolus administration every eight hours, for a maximum of eight doses.
Pembrolizumab
DrugIntravenous (IV) infusion
Treatment groups
85 Participants
are divided into 1 treatment groupGroup A: Biological Tumor Infiltrating Lymphocytes (TIL) Therapy with ImmunotherapyExperimental treatment 5 interventions
Trial outcomes
Primary outcomes
1
Adverse Events
To characterize the safety profile of (TIL) and natural autologous TIL in patients with advanced solid tumors who were failed to standard treatment as assessed by incidence of adverse events.
Time frame
6 monthsSecondary outcomes
1
Objective Response Rate (ORR)
Proportion of patients with response per Response Evaluation Criteria in Solid Tumors
Time frame
Up to 36 months2
Disease Control Rate (DCR）
Percentage of patients that meet CR, PR and SD criteria set in this study
Time frame
Up to 36 months3
Duration of Response (DOR)
The time length between the first confirmed objective response to the treatment and the subsequent disease progression
Time frame
Up to 36 months4
Progression-Free Survival (PFS)
The time length between TIL infusion and confirmed subsequent disease progression
Time frame
Up to 36 monthsSponsors and contacts
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Source ClinicalTrials.gov