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A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Background: KK-LC-1 is a cancer germline (CG) antigen with expression restricted to germ cells (which lack MHC class I expression) in adults and epithelial cancers including lung, breast and gastric. This limited expression pattern makes it an ideal target for T Cell Receptor (TCR) gene therapy. TCR T cell therapy targeting CG antigens has been shown to induce objective responses without autoimmunity or off-target toxicity in participants with melanoma, synovial sarcoma and cervical cancer T cells genetically engineered with a TCR targeting KK-LC-1 display specific reactivity against HLA-A01:01, KK-LC-1 target cells. KK-LC-1 TCR T cells can mediate tumor regression in pre-clinical mouse models of cancer Objective: To determine the maximally tolerated dose of KK-LC-1 TCR T cells plus aldesleukin for the treatment of metastatic KK-LC-1 positive epithelial cancers. Eligibility: Participants greater than or equal to 18 years old with metastatic or refractory/recurrent KK-LC-1 positive epithelial cancer. Prior first line systemic therapy is required unless the participant declines standard treatment. Participants must be HLA-A-01:01-positive. Design: This is a phase I clinical trial that will test the safety and efficacy of escalating doses of KK-LC-1 TCR T cells. Participants will receive a non-myeloablative lymphocyte-depleting preparative regimen of cyclophosphamide and fludarabine followed by a single infusion of KK-LC-1 TCR T cells and high-dose aldesleukin. Re-treatment will be allowed for a small number of subjects...

Bethesda, MarylandStart: September 2021