drugset / Trial / NCT02135406
CART-19 for Multiple Myeloma
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
Publications
- Garfall AL, Stadtmauer EA, Hwang WT, Lacey SF, Melenhorst JJ, Krevvata M, Carroll MP, Matsui WH, Wang Q, Dhodapkar MV, Dhodapkar K, Das R, Vogl DT, Weiss BM, Cohen AD, Mangan PA, Ayers EC, Nunez-Cruz S, Kulikovskaya I, Davis MM, Lamontagne A, Dengel K, Kerr ND, Young RM, Siegel DL, Levine BL, Milone MC, Maus MV, June CH. Anti-CD19 CAR T cells with high-dose melphalan and autologous stem cell transplantation for refractory multiple myeloma. JCI Insight. 2018 Apr 19;3(8):e120505. doi: 10.1172/jci.insight.120505. eCollection 2018 Apr 19.
- Garfall AL, Maus MV, Hwang WT, Lacey SF, Mahnke YD, Melenhorst JJ, Zheng Z, Vogl DT, Cohen AD, Weiss BM, Dengel K, Kerr ND, Bagg A, Levine BL, June CH, Stadtmauer EA. Chimeric Antigen Receptor T Cells against CD19 for Multiple Myeloma. N Engl J Med. 2015 Sep 10;373(11):1040-7. doi: 10.1056/NEJMoa1504542.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CART-19 T cells | Cell therapy | 1e+08 cells | Intravenous |
| Subject | CART-19 T cells | Cell therapy | 5e+08 cells | Intravenous |