CAR T-Cell Therapy Demonstrates Promising Results for mCRPC

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A total of 14 patients were treated between August 2019 and July 2022. The median patient age was 62 in dose level 1 (DL1), 70 for dose level 2 (DL2), and 69 for dose level 3 (DL3). The baseline prostate-specific antigen (PSA) ranged from 16.5 ng/mL to 235.3 ng/mL.

Primary end points were safety and dose-limiting toxicities. Secondary end points were expansion and persistence of CAR T cells to 28 days post-infusion, disease response by PSA decline and RECIST, and survival described as patient survival at 6 months.

Declines in PSA levels before treatment to day 28 after CAR T-cell therapy infusion were observed in 1 of 3 of patients in DL1, 3 of 6 in DL2, and 3 of 5 in DL3. Additionally, 4 patients across DLs experienced PSA level declines of more than 30%, and only 1 patient maintained it beyond 28 days.

One patient in DL1 experienced a transient PSA response linked to early neuroendocrine expression in the on-study biopsy and 1 within the DL2 cohort achieved a PSA decline greater than 90% in the first 28 days post-CAR T cell infusion.

Rates of stable disease by RECIST were 0% in DL1, 67% in DL2, and 60%, and a 33%, 67%, and 40% 6-month survival rate, respectively. Furthermore, cytokeratin (CK)-positive cells were detected in 100% of patients, with marked declines in mean CK-positive from baseline to 28 days after treatment in DL2 and Dl3 cohorts, but not in DL1.

Dose-limiting toxicities did not occur in the DL1 and DL3 cohorts, however, 2 patients in DL2 did. Additionally, CRS was observed in 1 patient in DL1, 2 in DL2, and 2 in DL3. The median onset of CRS was 4 days (range 3-8 days), with no instances at grade 3 severity.

Grade 3 AEs in DL1 included 2 patients having anemia, and 1 patient having decreased lymphocyte count. In DL2, 2 patients had anemia, 2 had fatigue, and 1 had pain. In DL3, 1 patient had decreased lymphocyte count.

“The patient’s results were very encouraging, and we are deeply grateful for his participation in our study as well as other patients and their families. We want to continue with this therapy and increase the amount of CAR T cells, and continue to carefully monitor for any health problems, as we think this can improve the therapy’s effectiveness,” Dorff concluded.

Source:

cancernetwork.com/view/car-...