A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors
Clinical Trial Information
Trial Contact: Donaldson, Karin M; Frankos, Marie
To evaluate the efficacy of autologous TIL LN-144/LN-145 as a single therapy in NSCLC patients or in combination with pembrolizumab in MM and HNSCC patients by determining the objective response rate (ORR), using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), as assessed by Investigator.
• To characterize the safety profile of TIL LN-144/LN-145 as a single-therapy in NSCLC patients or in combination with pembrolizumab in MM and HNSCC patients as measured by the incidence of Grade ≥3 treatment emergent adverse events (TEAEs).
1. All patients must have a histologically confirmed unresectable or metastatic
melanoma (Cohort 1), recurrent or metastatic squamous cell carcinoma of the
head and neck (Cohort 2), or recurrent or metastatic non-small cell lung cancer
(Cohort 3). Primary tumor histologic diagnosis confirmation required via
pathology report for all patients.
2. Cohort 1 and Cohort 2 only: patients who have not received prior
immunotherapy, including checkpoint inhibitors (eg, anti-PD-1/anti-PD-L1
and/or anti-CTLA-4). With the excluded prior therapies cited, patients may
have received from 1 to 3 prior systemic anticancer therapies, specifically:
• In Cohort 1: Patients with unresectable or metastatic melanoma
(Stage IIIC or Stage IV); if BRAF mutation-positive, patients may have
received a BRAF inhibitor.
• In Cohort 2: Patients with unresectable or metastatic HNSCC. Those who
may have received initial chemo-radiotherapy are allowed.
3. Cohort 3 only: Patients with Stage III or Stage IV NSCLC (squamous,
nonsquamous, adenocarcinoma, or large cell carcinoma) who have received
from 1 to 3 prior systemic anticancer therapies, including checkpoint inhibitors
(eg, anti-PD-1/anti-PD-L1) in the locally advanced or metastatic setting.
4. Patients must have at least 1 resectable lesion of a minimum 1.5 cm in
diameter post-resection for TIL investigational product production. It is
encouraged that tumor tissue be obtained from multiple and diverse metastatic
lesions, as long as the surgical resection it does not pose additional risks to the
• If the lesion considered for resection for TIL generation is within a
previously irradiated field, the lesion must have demonstrated
radiographic progression prior to resection;
• Patients must have an adequate histopathology specimen for protocol required testing (see Section 5.20).
5. Patients must have a remaining measurable disease as defined by RECIST 1.1
following tumor resection for TIL manufacturing:
• Lesions in previously irradiated areas should not be selected as target
lesions unless there has been demonstrated progression in those lesions;
6. Patients must be ≥18 years and ≤70 years of age at the time of consent.
Enrollment of patients >70 years of age may be allowed after consultation with
the Medical Monitor.
7. Patients must have an Eastern Cooperative Oncology Group (ECOG)
performance status of 0 or 1, and an estimated life expectancy of ≥3 months in
the opinion of the Investigator.
8. Patients of childbearing potential or their partners of childbearing potential
must be willing to practice an approved method of birth control during
treatment and for 12 months after receiving all protocol-related therapy
(Note: Females of reproductive potential are to use effective contraception