Pts may receive optional bridging therapy and receive lymphodepleting chemotherapy with fludarabine 30mg/m2/day and cyclophosphamide 300mg/m2/day (Flu-Cy), for 3 days followed by LB1901. Secondary endpoints include overall response rate; duration of response; CAR-positive T cell counts and CAR transgene level in blood; and presence of anti-CAR antibody response. Exploratory endpoints include preliminary efficacy, pharmacokinetics, and CD4+ T cell counts.
Altogether, the in vitro and in vivo studies showed that LB1901 did not ?mask? the CD4 antigen but exhibited potent anti-tumor activity without off-target effects . A phase 1 study of LB1901 CAR-T in patients with relapsed or refractory PTCL or CTCL is ongoing in the US to assess the safety and tolerability of LB1901 CAR-T (NCT04712864).
almost 5 years ago
Preclinical • CAR T-Cell Therapy
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)