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Metastatic Triple Negative Breast CancerPhase 2NCT04111510

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

A Phase 2 study testing Tumor infiltrating lymphocytes (TIL) LN-145 in people with Metastatic Triple Negative Breast Cancer, run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Triple Negative Breast Cancer
What is being tested?
Tumor infiltrating lymphocytes (TIL) LN-145
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
23 Dec 2019to 11 May 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 disease progression from the last line of therapy.
  • 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.
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  • 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 the following hematologic parameters:
  • Absolute neutrophil count (ANC) ≥ 1000/mm3;
  • Hemoglobin ≥ 9.0 g/dL;
  • Platelet count ≥ 100,000/mm3
  • 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 21 days from last anticancer therapy prior to the first study treatment (ie, start of NMA LD).
  • Palliative radiation therapy: prior external beam radiation is allowed provided all radiation-related toxicities are resolved to Grade 1 or baseline;
  • The tumor lesion(s) being assessed as target for response via RECIST 1.1 must be outside of the radiation portal (however, if within the portal, they must have demonstrated progression);
  • Surgery/pre-planned procedure: previous surgical procedure(s) is permitted provided that wound healing has occurred, all complications have resolved, and at least 14 days have elapsed (for major operative procedures) prior to the tumor resection.
  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Yale School of Medicine

    New Haven, Connecticut, 06520

Other trials in United States

About this study

Official title: A Phase 2 Study of Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients With Pretreated Metastatic Triple Negative Breast Cancer

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.

Read the detailed description

The primary aims of the study are:

  • To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer (TNBC) patients by determining the objective response rate (ORR), using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the Investigator.
  • To characterize the safety profile of tumor infiltrating lymphocytes (TIL) as a single therapy in Metastatic Triple Negative Breast Cancer patients as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs).

The secondary aims of the study are:

  • To further evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer patients using complete response duration of response (DOR), disease control rate (DCR), and progression-free survival (PFS), using RECIST 1.1, as assessed by the Investigator, overall survival (OS) and (CR) rate.
Being tested
Tumor infiltrating lymphocytes (TIL) LN-145
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tumor infiltrating lymphocytes (TIL) LN-145Drug

    The TIL autologous therapy with LN-145 is comprised of the following steps:

    1. Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
    2. LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
    3. A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
    4. Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
    5. Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization).
Study groups in NCT04111510
Study groupRoleWhat they receive
LN-145ExperimentalLN-145 will be delivered as a single therapy in patients with Metastatic Triple Negative Breast Cancer.
Receives: Drug: Tumor infiltrating lymphocytes (TIL) LN-145

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer (TNBC) patients by determining the objective response rate (ORR), using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, as assessed by the Investigator. Upon results entry, the time frame was updated to reflect the latest time point that a participant was assessed for ORR in the study.

    Measured: Up to 4 months

  2. Safety Profile

    To characterize the safety profile of tumor infiltrating lymphocytes (TIL) as a single therapy in Metastatic Triple Negative Breast Cancer patients as measured by the incidence of Grade ≥ 3 treatment-emergent adverse events (TEAEs). Incidence is presented as a count of participants that experienced at least 1 TEAE of Grade ≥ 3.

    Measured: Up to 3 years

Secondary outcomes (5)

  1. Duration of Response (DOR) in Days

    To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer patients in participants that have a clinical response (either partial response (PR) or complete response (CR)) using duration of response (DOR), using RECIST 1.1, as assessed by the Investigator will be used.

    Measured: Up to 3 years

  2. Disease Control Rate (DCR)

    To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer patients using disease control rate (DCR), using RECIST 1.1, as assessed by the Investigator will be used. Percentage of patients whose disease shrinks or remains stable over a certain time period.

    Measured: Up to 3 years

  3. Progression-free Survival (PFS)

    To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast Cancer patients, median progression-free survival (PFS) days, using RECIST 1.1, as assessed by the Investigator will be used.

    Measured: Up to 3 years

  4. Overall Survival (OS)

    To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast patients overall survival (OS) median days will be used.

    Measured: Up to 3 years

  5. Complete Response (CR)

    To evaluate the efficacy of autologous LN-145 as a single therapy in Metastatic Triple Negative Breast patients complete response, using RECIST 1.1, as assessed by the Investigator will be used. The number of participants with a complete response.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start23 Dec 2019
  3. Primary completion30 Jan 2023
  4. Study completion11 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04111510
Sponsor's protocol ID
2000025837
Status last verified
Nov 2024
First submitted
30 Sep 2019
Last updated
21 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gautam N, Elleson KM, Ramamoorthi G, Czerniecki BJ. Current State of Cell Therapies for Breast Cancer. Cancer J. 2022 Jul-Aug 01;28(4):301-309. doi: 10.1097/PPO.0000000000000607.

    PubMed 35880940

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tumor infiltrating lymphocytes (TIL) LN-145 in people with Metastatic Triple Negative Breast Cancer, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: Up to 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04111510, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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