Autologous Tumor Infiltrating Lymphocytes in Patients With Pretreated Metastatic Triple Negative Breast Cancer

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will investigate the safety and efficacy of TIL therapy in patients with metastatic TNBC who have progressed on at least one and no more than three prior systemic anticancer therapies.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Iovance Biotherapeutics, Inc.

Criteria

Inclusion Criteria:

• Ability to understand the requirements of the study. Specifically, the patient has to provide written informed consent (as evidenced by signature on an ICF approved by the Yale Human Investigation Committee (HIC).

• All patients must have a triple negative metastatic breast cancer (Estrogen Receptor negative, Progesterone Receptor negative, HER2 negative) as defined by the 2018 ASCO CAP guidelines.

• Patients must have a confirmed diagnosis of metastatic triple negative breast cancer (Stage IV) histologically confirmed as per American Joint Committee on Cancer [AJCC] staging system).

• Patients must have had at least one and no more than three prior lines of systemic anticancer therapies for metastatic disease.

• Patients must have at least one resectable lesion of a minimum 1.5 cm in diameter (or aggregate of 1.5 cm if multiple lesions are sampled) post-resection for TIL investigational product production.

• Patients must have remaining measurable disease as defined by RECIST 1.1 following tumor resection for TIL manufacturing

• Patients must be ≥ 18 years of age at the time of consent.

• 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.

• Female patients of childbearing potential or female partners of childbearing potential of male participants, must be willing to practice an approved method of birth control during treatment and for 12 months after receiving all protocol-related therapy.

• Patients must have adequate bone marrow function

• Patients must have adequate organ function:

• Patients must be seronegative for the human immunodeficiency virus (HIV1 and HIV2).

• Patients must have a washout period of 5 half-lives from last anticancer therapy prior to the first study treatment (ie, start of NMA-LD).

• Patients must have recovered from all prior anticancer treatment-related adverse events (TRAEs) to Grade ≤ 1 (per Common Terminology Criteria for Adverse Events [CTCAE], version 5.0).

• Patients must have provided written authorization for use and disclosure of protected health information.

• Must be able and willing to comply with the study visit schedule and protocol requirements including long-term follow-up (LTFU).

Exclusion Criteria:

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

• Patients with symptomatic and/or untreated brain metastases:

• Patients who are on systemic steroid therapy except for those requiring steroid for management of adrenal insufficiency.

• Patients who are pregnant or breastfeeding.

• Patients who have active medical illness(es) that would pose increased risk for study participation

• Patients who have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD.

• Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease [SCID] and acquired immune deficiency syndrome [AIDS]).

• 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 (NYHA) Class II or higher.

• Patients who have obstructive or restrictive pulmonary disease and have a documented FEV1 (forced expiratory volume in 1 second) ≤ 60% of predicted normal.

• Patients who have had another primary malignancy within the previous 3 years (except for curatively treated localized malignancy that has not required treatment for greater than 1 year.

• Participation in another clinical study with an investigational product within 21 days of the initiation of NMA-LD treatment.