Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)
Summary
This is a Phase 2, open-label, multicenter study to determine the efficacy and safety of lisocabtagene maraleucel (JCAR017) in adult subjects who have relapsed from, or are refractory to, a single line of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) and are ineligible for hematopoietic stem cell transplant (based on age, performance status, and/or comorbidities). Subjects will receive treatment with lisocabtagene maraleucel and will be followed for 2 years for safety, pharmacokinetics and biomarkers, disease status, quality of life, and survival.
Timeline
- Start
- 2018-07-27
- Primary completion
- 2021-09-24
- Completion
- 2022-12-01
Outcome
Met primary endpoint
paper Overall response rate (primary end point) was 80%; 54% achieved complete response. PMID 40305658 ↗
paper 49 (80% [95% CI 68-89]; p<0·0001) patients had an overall response. PMID 35839786 ↗
Publications
- Sehgal A, Hoda D, Riedell PA, Ghosh N, Hamadani M, Hildebrandt GC, Godwin JE, Reagan PM, Wagner-Johnston ND, Essell J, Nath R, Solomon SR, Champion R, Licitra E, Fanning S, Gupta NK, Chow VA, Yuan B, Yang Z, Ogasawara K, Thorpe J, Gordon LI. Lisocabtagene maraleucel for R/R LBCL in patients not intended for HSCT: final results of the phase 2 PILOT study. Blood Adv. 2025 Aug 12;9(15):3694-3705. doi: 10.1182/bloodadvances.2024015262.
- Ghosh N, Sehgal A, Liu FF, Kostic A, Crotta A, De Benedetti M, Faccone J, Peng L, Gordon LI. Comparative efficacy of lisocabtagene maraleucel in the PILOT study versus second-line chemotherapy regimens in the real world. Haematologica. 2025 Mar 1;110(3):693-705. doi: 10.3324/haematol.2024.285828.
- Gordon LI, Liu FF, Braverman J, Hoda D, Ghosh N, Hamadani M, Hildebrandt GC, Peng L, Guo S, Shi L, Sehgal A. Lisocabtagene maraleucel for second-line relapsed or refractory large B-cell lymphoma: patient-reported outcomes from the PILOT study. Haematologica. 2024 Mar 1;109(3):857-866. doi: 10.3324/haematol.2023.283162.
- Sehgal A, Hoda D, Riedell PA, Ghosh N, Hamadani M, Hildebrandt GC, Godwin JE, Reagan PM, Wagner-Johnston N, Essell J, Nath R, Solomon SR, Champion R, Licitra E, Fanning S, Gupta N, Dubowy R, D'Andrea A, Wang L, Ogasawara K, Thorpe J, Gordon LI. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022 Aug;23(8):1066-1077. doi: 10.1016/S1470-2045(22)00339-4. Epub 2022 Jul 12.
- Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lisocabtagene Maraleucel | Cell therapy | 1e+08 cells | Intravenous |