drugset / Trial / NCT02135406

CART-19 for Multiple Myeloma

NCT02135406 ↗

Phase 1 Completed 13 enrolled University of Pennsylvania
NaSingle-groupOpen-labelTreatment

Summary

The primary goals: determine the safety, tolerability and engraftment potential of CART-19 T cells in patients undergoing salvage ASCT after early relapse following first ASCT. CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR(zeta):41BB administered by intravenous infusion using a single infusion of 1-5x108 CART19-transduced T cells on day +2 after autologous stem cell infusion following high-dose melphalan.

Timeline

Start
2014-05
Primary completion
2015-09
Completion
2018-01-18

Drugs

EvaluationDrugModalityDoseRoute
Subject CART-19 T cells Cell therapy 1e+08 cells Intravenous
Subject CART-19 T cells Cell therapy 5e+08 cells Intravenous

Indications