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A phase I/II trial of CD3/CD28 activated T cells (Xcellerated T Cells) in patients with hormone refractory prostate cancer.

2549 Background: T cells can be activated and expanded ex vivo from peripheral blood mononuclear cells using paramagnetic beads coated with antibodies to the CD3 and CD28 receptors (Xcellerate Process).


METHODS
Patients with androgen independent prostate cancer and no history of prior chemotherapy were enrolled. Patients received one infusion of 75-100 x 109 CD3/CD28 activated T cells (Xcellerated T Cells). Objectives of the study were to assess the safety of the therapy, changes in serum prostate specific antigen (PSA), and changes in markers of bone resorption.


RESULTS
20 patients underwent leukapheresis, and 19 were treated (1 patient progressed prior to treatment). Baseline characteristics for the treated patients [median(range)] were: age 71.1 (55.1-84.4), PSA 28.2 ng/mL (6.2-348.0), and Gleason score 7 (4-9). Ten patients had documented bone metastases. Xcellerated T Cells were successfully manufactured in all patients. T cells expanded 125 ± 33 fold (mean ± S.D.). The final products were 99.1 ± 1.4% T cells with CD4:CD8 ratio of 5.2 ± 4.0. The mean number of viable cells infused was 84 ± 18 x 109. Toxicities possibly, probably or definitely related to the therapy of Grade 1, 2 or 3 severity were seen in 13, 3 and 1 patients respectively. The most common toxicities were rigors, pyrexia and nausea. The lymphocyte count per mm3 increased from 1218 ± 156 at Day 0, to 3455 ± 355 at Day 7 and 2756 ± 393 at Month 4 (mean ± SEM). Two patients had PSA declines of >50%, with PSA nadirs occuring 5 and 14 months following treatment. Serum markers of bone resorption (NTX, BAP, ICTP) measured in 5 patients with positive bone scans were not statistically different at Month 3 compared with baseline.


CONCLUSIONS
Xcellerated T Cells can be delivered on an outpatient basis with few side effects, and result in sustained increases in lymphocyte counts, and significant PSA declines in some patients. [Table: see text].