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

Recruiting in Palo Alto (17 mi)

Overseen byMichael Hurwitz, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yale University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new treatment that uses a patient's own immune cells to fight metastatic Triple Negative Breast Cancer. It targets patients who have not responded well to previous treatments. The therapy aims to boost the body's natural defenses against cancer.

Eligibility Criteria

Inclusion Criteria

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.

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.

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).

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Exclusion Criteria

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

You are taking steroids for any reason other than managing adrenal insufficiency.

You have a medical condition that could make it more dangerous for you to participate in the study.

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