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.
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.
Participant has ongoing toxicity ≥ grade 2 per the CTCAE version 5.0 considered clinically significant and in the opinion of the investigator, attributable to prior antineoplastic therapies.
Participant has received any chemotherapy or other immunotherapy within 14 days prior to the first dose of study intervention.
Unstable angina and/or congestive heart failure requiring hospitalization.
Transmural myocardial infarction within the last 6 months.
Single group
Ex-Vivo expanded autologous IL-8 receptor (CXCR2) modified CD70 CAR (8R-70CAR) T cells
Biological/VaccineSingle dose of 8R-70CAR T cells administered IV
Number and percentage of participants with dose-limiting toxicities after receiving 8R-70CAR T-cell therapy
Safety is defined as ≤ 1 DLT out of 6 patients is observed at the 1x10\^8 cells/Kg dose. Dose-Limiting toxicity (DLT) will be defined as any adverse event attributable (possible, probable, or definite) to the administration of 8R-70CAR T cells and occurring from the time of infusion through 28 days post-infusion. Safety variables and variables that define the DLTs will be summarized using descriptive statistics by dose level. Number and percentage of patients with DLTs and its 95% confidence interval (CI) will be estimated based on the exact binomial distribution by dose level.
Proportion of participants who receive an infusion of 8R-70CAR T-cell therapy
Feasibility will be defined as the ability to infuse 8R-70CAR T-cell safely in 66.7 % of enrolled patients (patients who signed consent and were deemed eligible for the study).
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