University of Florida
This is a Phase I Study evaluating the safety and feasibility of IL-8 receptor-modified patient-derived activated CD70 CAR T cells in adult patients with brain metastases from primary cancer, with either newly diagnosed lesions or recurrent or progressive disease after prior therapy.
Adult patients with newly diagnosed or recurrent/progressive brain metastases will be screened. Consented patients will undergo screening procedures followed by tumor biopsy/surgery if clinically indicated, and may receive treatment for brain metastases, which include whole brain radiation therapy (WBRT), SRS treatment for new lesion(s) (SRS is permitted for recurrent disease only for newly developed brain lesion(s). After enrollment, patients will be evaluated for cellular therapy suitability and undergo cell collection for the generation of 8R-70CAR T cells before initiation or up to two cy…
Inclusion Criteria: * Histological confirmation of primary cancers * Histologic confirmation of CD70 on primary tumor, lymph node, or BM biopsy * At least one recurrent or progressive metastatic lesion or new metastatic lesion(s). * KPS ≥ 70. * 18 years or older. * Adequate bone marrow and organ function as defined below: * CBC with differential with adequate bone marrow function as defined below: * Absolute neutrophil count (ANC) ≥ 10000 cells/mm3. * Platelet count ≥ 75,000 cells/mm3. * Hemoglobin ≥ 9 g/dl. (use of transfusion or other intervention to achieve Hgb ≥ 9 g/dl is accepta…
Single dose of 8R-70CAR T cells administered IV
Arctuva estimate
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