Clinical trial · no report yet · Phase 1
TRANSCEND-NHL-001
Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)
- NCT02631044 ↗
- Completed
- Juno Therapeutics, a Subsidiary of Celgene
- Deep
We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.
Preliminary discovery
Commentary in our index that names this trial so far
Podcasts, YouTube videos and X posts we have indexed. A report screens them, searches for more and cites what clinicians said when it is built, so final coverage is set at build.
| Channel | Found | |
|---|---|---|
| X threads | 21 | |
| Podcasts | 6 | |
| YouTube | 3 |
The trial
ClinicalTrials.gov- Official title
- A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL)
- Phase
- Phase 1
- Status
- Completed
- Conditions
- Non-Hodgkin Lymphoma; Diffuse Large B Cell Lymphoma; Follicular Lymphoma; Mantle-cell Lymphoma; Primary Mediastinal B-cell Lymphoma
- Interventions
- JCAR017 (lisocabtagene maraleucel) single-dose schedule; JCAR017 (lisocabtagene maraleucel) 2-dose schedule
- Arms
- JCAR017 1-dose schedule · Experimental
- JCAR017 2-dose schedule (no longer accruing) · Experimental
- Enrollment
- 387
- Primary outcomes
- Treatment-related adverse events (AEs) as assessed by CTCAE v4.03
- Dose-limiting toxicities of JCAR017
- Objective response rate (ORR)
- Sponsor
- Juno Therapeutics, a Subsidiary of Celgene
- Start
- Jan 6, 2016
- Primary completion
- May 16, 2024
- Results posted
- No
- Registry record
- NCT02631044 · updated Jun 27, 2024
Publications
linked from the registry- Abramson JS, Siddiqi T, Gordon LI, Lunning MA, Wang M, Arnason JE, Kamdar M, Maloney DG, Shadman M, Andreadis CB, Sehgal A, Solomon SR, Ghosh N, Hidalgo-Lopez JE, Wang J, Ding X, Ogasawara K, Singh A, Palomba ML. Five-year survival outcomes from TRANSCEND NHL 001 of lisocabtagene maraleucel in R/R LBCL. Blood. 2026 Jun 3:blood.2025032270. doi: 10.1182/blood.2025032270. Online ahead of print. PubMed 42237652
- Wang M, Siddiqi T, Gordon LI, Kamdar M, Lunning M, Hirayama AV, Abramson JS, Arnason J, Ghosh N, Mehta A, Andreadis C, Solomon SR, Kostic A, Dehner C, Espinola R, Peng L, Ogasawara K, Chattin A, Eliason L, Palomba ML. Lisocabtagene Maraleucel in Relapsed/Refractory Mantle Cell Lymphoma: Primary Analysis of the Mantle Cell Lymphoma Cohort From TRANSCEND NHL 001, a Phase I Multicenter Seamless Design Study. J Clin Oncol. 2024 Apr 1;42(10):1146-1157. doi: 10.1200/JCO.23.02214. Epub 2023 Dec 10. PubMed 38072625
- Abramson JS, Palomba ML, Gordon LI, Lunning M, Wang M, Arnason J, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Dehner C, Kim Y, Ogasawara K, Kostic A, Siddiqi T. Two-year follow-up of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphoma in TRANSCEND NHL 001. Blood. 2024 Feb 1;143(5):404-416. doi: 10.1182/blood.2023020854. PubMed 37890149
- Van Le H, Van Naarden Braun K, Nowakowski GS, Sermer D, Radford J, Townsend W, Ghesquieres H, Menne T, Porpaczy E, Fox CP, Schusterbauer C, Liu FF, Yue L, De Benedetti M, Hasskarl J. Use of a real-world synthetic control arm for direct comparison of lisocabtagene maraleucel and conventional therapy in relapsed/refractory large B-cell lymphoma. Leuk Lymphoma. 2023 Mar;64(3):573-585. doi: 10.1080/10428194.2022.2160200. Epub 2023 Feb 8. PubMed 36755418
- Teoh J, Brown LF. Developing lisocabtagene maraleucel chimeric antigen receptor T-cell manufacturing for improved process, product quality and consistency across CD19+ hematologic indications. Cytotherapy. 2022 Sep;24(9):962-973. doi: 10.1016/j.jcyt.2022.03.013. Epub 2022 May 21. PubMed 35610089
- Cartron G, Fox CP, Liu FF, Kostic A, Hasskarl J, Li D, Bonner A, Zhang Y, Maloney DG, Kuruvilla J. Matching-adjusted indirect treatment comparison of chimeric antigen receptor T-cell therapies for third-line or later treatment of relapsed or refractory large B-cell lymphoma: lisocabtagene maraleucel versus tisagenlecleucel. Exp Hematol Oncol. 2022 Mar 25;11(1):17. doi: 10.1186/s40164-022-00268-z. PubMed 35337365
- Ogasawara K, Lymp J, Mack T, Dell'Aringa J, Huang CP, Smith J, Peiser L, Kostic A. In Vivo Cellular Expansion of Lisocabtagene Maraleucel and Association With Efficacy and Safety in Relapsed/Refractory Large B-Cell Lymphoma. Clin Pharmacol Ther. 2022 Jul;112(1):81-89. doi: 10.1002/cpt.2561. Epub 2022 Mar 20. PubMed 35156195
- 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. PubMed 34515338
- Maloney DG, Kuruvilla J, Liu FF, Kostic A, Kim Y, Bonner A, Zhang Y, Fox CP, Cartron G. Matching-adjusted indirect treatment comparison of liso-cel versus axi-cel in relapsed or refractory large B cell lymphoma. J Hematol Oncol. 2021 Sep 8;14(1):140. doi: 10.1186/s13045-021-01144-9. PubMed 34493319
- Westin JR, Kersten MJ, Salles G, Abramson JS, Schuster SJ, Locke FL, Andreadis C. Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials. Am J Hematol. 2021 Oct 1;96(10):1295-1312. doi: 10.1002/ajh.26301. Epub 2021 Aug 13. PubMed 34310745
- Ogasawara K, Dodds M, Mack T, Lymp J, Dell'Aringa J, Smith J. Population Cellular Kinetics of Lisocabtagene Maraleucel, an Autologous CD19-Directed Chimeric Antigen Receptor T-Cell Product, in Patients with Relapsed/Refractory Large B-Cell Lymphoma. Clin Pharmacokinet. 2021 Dec;60(12):1621-1633. doi: 10.1007/s40262-021-01039-5. Epub 2021 Jun 14. PubMed 34125421
- Salles G, Spin P, Liu FF, Garcia J, Kim Y, Hasskarl J. Indirect Treatment Comparison of Liso-Cel vs. Salvage Chemotherapy in Diffuse Large B-Cell Lymphoma: TRANSCEND vs. SCHOLAR-1. Adv Ther. 2021 Jun;38(6):3266-3280. doi: 10.1007/s12325-021-01756-0. Epub 2021 May 10. PubMed 33970454
- Patrick DL, Powers A, Jun MP, Kim Y, Garcia J, Dehner C, Maloney DG. Effect of lisocabtagene maraleucel on HRQoL and symptom severity in relapsed/refractory large B-cell lymphoma. Blood Adv. 2021 Apr 27;5(8):2245-2255. doi: 10.1182/bloodadvances.2020003503. PubMed 33904895
- Abramson JS, Siddiqi T, Garcia J, Dehner C, Kim Y, Nguyen A, Snyder S, McGarvey N, Gitlin M, Pelletier C, Jun MP. Cytokine release syndrome and neurological event costs in lisocabtagene maraleucel-treated patients in the TRANSCEND NHL 001 trial. Blood Adv. 2021 Mar 23;5(6):1695-1705. doi: 10.1182/bloodadvances.2020003531. PubMed 33720336
- Abramson JS, Palomba ML, Gordon LI, Lunning MA, Wang M, Arnason J, Mehta A, Purev E, Maloney DG, Andreadis C, Sehgal A, Solomon SR, Ghosh N, Albertson TM, Garcia J, Kostic A, Mallaney M, Ogasawara K, Newhall K, Kim Y, Li D, Siddiqi T. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020 Sep 19;396(10254):839-852. doi: 10.1016/S0140-6736(20)31366-0. Epub 2020 Sep 1. PubMed 32888407