P1/2, N=100, Recruiting, Shenzhen Geno-Immune Medical Institute | Trial completion date: Dec 2023 --> Dec 2030 | Trial primary completion date: Nov 2020 --> Dec 2029
1 day ago
Trial completion date • Trial primary completion date
P1/2, N=100, Recruiting, Shenzhen Geno-Immune Medical Institute | Trial completion date: Dec 2024 --> Dec 2030 | Trial primary completion date: Oct 2023 --> Oct 2029
1 day ago
Trial completion date • Trial primary completion date
P-PSMA-101 is a first-in-class, stem cell memory T cell-enriched, PSMA-targeting CAR-T therapy. This cellular therapy showed notable clinical activity in two patients; however, PSA50 responses were generally modest. While severe immune effector-related toxicities were observed in some patients, a novel iCasp9 safety switch was largely effective in mitigating toxicity.
Robust expansion of P-PSMA-101 CAR T cells resulted in toxicity but also durable responses in patients with mCRPC. Future trials of CAR T may be informed by the results with this nonviral engineering, TSCM cell-enriched approach.
P1, N=13, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Jun 2025 --> Jun 2026
12 months ago
Trial completion date • Trial primary completion date
Herein, we develop an approach for in situ T cell generation, tracking, and functional assessment using anti-CD5-conjugated lipid nanoparticles for codelivering CD19 CAR mRNA (mCAR19) and a prostate-specific membrane antigen mRNA (mPSMA) tag. With interleukin-7 (IL-7) preconditioning and repeated administration, this approach achieves tumor-free survival in 75% of B cell lymphoma-bearing mice (similar efficacy to ex vivo approaches), and through PET imaging of 68Ga-PSMA-617, the generation and tumor infiltration of in situ-engineered PSMA-tagged CD19 CAR-T cells is validated.