Phase 1 Trial of P-PSMA-101 CAR-T Cells in Patients with Metastatic Castration Resistant Prostate Cancer (mCRPC) - PubMed
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- #Clinical Trial
- #CAR-T therapy
- #Prostate Cancer
- Phase 1 trial evaluated P-PSMA-101 CAR-T cells in metastatic castration-resistant prostate cancer (mCRPC).
- P-PSMA-101 is an autologous TSCM-rich CAR-T therapy targeting PSMA, produced using piggyBac® DNA transposon platform.
- 33 patients were treated, with 18% experiencing dose-limiting toxicities (DLTs).
- Cytokine release syndrome (CRS) occurred in 61% of patients, with Grade ≥ 3 CRS in 9%.
- iCasp9 safety switch was activated in 24% of cases, including one fatal toxicity.
- 21% of patients showed ≥50% PSA decline, and one partial response was observed among RECIST-evaluable patients.
- 61% had stable disease, with 21% maintaining stability for ≥3 months.
- Two patients had remissions exceeding 12 months with PSA declines >90%.
- Results suggest robust CAR-T expansion leads to toxicity but also durable responses in mCRPC.