A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting (TRANSCEND-OUTREACH-007)

Summary

This is an open-label, multicenter, Phase 2 study to determine the safety, PK, and efficacy of lisocabtagene maraleucel (JCAR017) in subjects who have relapsed from, or are refractory to, two lines of immunochemotherapy for aggressive B-cell non-Hodgkin lymphoma (NHL) in the outpatient setting. Subjects will receive treatment with JCAR017 and will be followed for up to 2 years.

Timeline

Start

2018-11-29

Primary completion

2023-09-22

Completion

2023-09-22

Publications

• Linhares Y, Freytes CO, Cherry M, Bachier C, Maris M, Hoda D, Varela JC, Bellomo C, Cross S, Essell J, Fanning S, Terebelo H, Yimer H, Courtright J, Sharman JP, Kostic A, Vedal M, Ogasawara K, Avilion A, Espinola R, Yuan B, Mattar B. OUTREACH: phase 2 study of lisocabtagene maraleucel as outpatient or inpatient treatment at community sites for R/R LBCL. Blood Adv. 2024 Dec 10;8(23):6114-6126. doi: 10.1182/bloodadvances.2024013254.
• 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

Indications