Bellicum Pharmaceuticals has commenced patient treatment in the phase I dose escalation trial of BPX-201 dendritic cells along with activating agent AP1903 for the treatment of metastatic castrate resistant prostate cancer (mCRPC).
Designed to assess the safety, tolerability and clinical outcomes of BPX-201 and AP1903, the study will enrol 18 adult males with progressive mCRPC who are not exposed to prior chemotherapy.
Escalating doses of 10 million, 20 million and 40 million cells of BPX-201 will be administered in three cohorts of six patients for over six treatment cycles.
Every other week, patients will be given activating agent AP1903 around 24-hours after being administered the BPX-201. Following this, patients will be evaluated for safety, prostate specific antigen response, progression-free survival and reduction in circulating tumour cells.
Bellicum Pharmaceuticals CEO Tom Farrell said that the clinical study evaluates dendritic cells modified with the latest cell signalling switch designed to improve the effectiveness of cancer immunotherapy.
"We believe the ability to strategically delay immune activation until the trained cells have migrated to the lymph nodes may result in a more potent immune response," he said.
The patient's self-matured dendritic cells are engineered with DeCIDe and trained to target prostate cancer cells present in BPX-201.
As AP1903 is administered after the infusion of the modified cells into the patient, the body's T cells are lined up to target cancer.
A more potent and durable antigen-specific T cell immune response is expected to be achieved by waiting until the migration of modified dendritic cells to nearby lymph nodes before infusion.
Image: Micrograph of prostatic adenocarcinoma, conventional (acinar) type, the most common form of prostate cancer. Prostate biopsy. H&E stain. Photo: Nephron.