drugset / Trial / NCT02893189
CAR19 Donor Lymphocytes for Relapsed CD19+ Malignancies Following Allogeneic Transplantation
NaSingle-groupOpen-labelTreatment
Summary
Eligible patients will receive escalating doses of 4G7-CARD T-cells paralleling clinical standard of care with unmanipulated donor lymphocytes. There are 3 intra-patient dose levels planned. Patients will be followed up regularly during the interventional phase of the study until 12 months post-final 4G7-CARD T-cell infusion. Thereafter patients will be followed up annually for years 2 and 3.
Timeline
- Start
- 2017-04-27
- Primary completion
- 2019-12-31
- Completion
- 2022-12-31
Publications
- Roddie C, Dias J, O'Reilly MA, Abbasian M, Cadinanos-Garai A, Vispute K, Bosshard-Carter L, Mitsikakou M, Charalambous E, Mehra V, Roddy H, Cheung GW, Hartley JA, Mahmoud N, Ensell L, Patel Y, Marzolini MAV, Farzaneh F, Nickolay L, Himoudi N, Syed F, Popova B, Galani S, Day A, Lowdell MW, Peggs KS. Matched donor allogeneic CAR-T for adult B-ALL: toxicity, efficacy, repeat dosing, and the importance of lymphodepletion. Blood. 2025 Oct 2;146(14):1664-1676. doi: 10.1182/blood.2025028790.
- O'Reilly M, Roddie C, Marzolini MAV, Rodriguez-Justo M, Pomplun S, Pule M, Peggs KS. Trafficking of CAR T cells to sites of subclinical leukaemia cutis. Lancet Oncol. 2020 Mar;21(3):e179. doi: 10.1016/S1470-2045(19)30861-7. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | 4G7-CARD T-cells | Cell therapy | 1e+06 cells/kg | — |
| Subject | 4G7-CARD T-cells | Cell therapy | 3e+06 cells/kg | — |
| Subject | 4G7-CARD T-cells | Cell therapy | 1e+07 cells/kg | — |