Overview

Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
All
Summary
A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Iovance Biotherapeutics, Inc.
Treatments:
Ipilimumab
Nivolumab
Pembrolizumab
Criteria
Inclusion Criteria

- Must have a confirmed diagnosis of malignancy of their receptive histologies:
unresectable or metastatic melanoma Stage IIIC or Stage IV (Cohorts 1A,1B and 1C),
advanced, recurrent or metastatic HNSCC (Cohort 2A), or Stage III or Stage IV
non-small cell lung cancer (Cohorts 3A, 3B, and 3C).

- Cohorts 1A, 2A, and 3A: If previously treated, patients must have progressed on or
after most recent therapy and must not have received CPIs as part of one of the
counted lines of prior therapy. Patients must have radiologically documented disease
progression while receiving or after the completion of the most recent prior
treatment. Patients may have received up to 3 prior systemic anticancer therapies
(except for Cohort 3A, where patients whose tumors harbor actionable mutations may
have received up to 4 prior systemic therapies)

- Cohorts 1B, 1C, 3B, and 3C: Unresectable or metastatic melanoma patients in Cohorts 1B
or 1C must have previously received systemic therapy with a PD-1 blocking antibody.
NSCLC patients in Cohort 3B must have previously received systemic therapy with any
CPI (except for those patients with known oncogene drivers (eg, EGFR, ALK, ROS) who
have mutations that are sensitive to targeted therapies) as part of 1 - 3 prior lines
of therapy. NSCLC patients in Cohort 3C must have received prior systemic therapy with
an approved monotherapy CPI as their single prior line of systemic therapy.

- Must have at least 1 resectable lesion

- Must have a remaining measurable disease as defined by RECIST 1.1 following tumor
resection

- Must be ≥ 18 years at the time of consent for Cohorts 1A, 1C, 2A, 3A, 3B, and 3C.
Patients must be ≥ 12 years at the time of consent for Cohort 1B. Enrollment of
patients > 70 years of age may be allowed after consultation with the Medical Monitor.

- Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
and an estimated life expectancy of ≥ 6 months.

- Patients of childbearing potential or those with 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.

Exclusion Criteria

- Patients with melanoma of uveal/ocular origin.

- Patients who have received an organ allograft or prior cell transfer therapy that
included a nonmyeloablative or myeloablative chemotherapy regimen within the past 20
years.

- Patients with symptomatic and/or untreated brain metastases

- Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or other
steroid equivalent. Patients receiving steroids as replacement therapy for
adrenocortical insufficiency at ≤ 10 mg/day of prednisone or other steroid equivalent
may be eligible.

- Patients who are pregnant or breastfeeding.

- Patients who have an active medical illness(es), which in the opinion of the
Investigator, would pose increased risks for study participation

- Cohort 1A, 2A, 3A, and 3C patients may not have a medical history of autoimmune
disorders (including pneumonitis) requiring treatment or active management.

- Patients who have received a live or attenuated vaccination within 28 days prior to
the start of treatment

- Patients who have any form of primary immunodeficiency

- Patients with a history of hypersensitivity to any component of the study drugs

- Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New
York Heart Association Class II or higher

- Patients with respiratory dysfunction or history of smoking are excluded if not
meeting either of forced expiratory volume in 1 second (FEV1)/forced vital capacity
(FVC) > 0.7 or FEV1 > 50%.

- Patients who have had another primary malignancy within the previous 3 years

- Participation in another interventional clinical study within 21 days of the
initiation of treatment.