A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

Summary

This is a global Phase 2, open-label, single-arm, multicohort, multicenter study to evaluate efficacy and safety of JCAR017 in adult subjects with r/r FL or MZL. The study will be conducted in compliance with the International Council on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good Clinical Practice (GCP) and applicable regulatory requirements. This study is divided into three periods: * Pretreatment, which consists of screening assessments, leukapheresis and the Pretreatment evaluation; * Treatment, which starts with the administration of lymphodepleting (LD) chemotherapy and continues through JCAR017 administration at Day 1 with follow-up through Day 29; * Posttreatment, which includes follow-up assessments for disease status and safety for 5 years.

Timeline

Start

2020-07-14

Primary completion

2031-09-30

Completion

2031-09-30

Outcome

Met primary endpoint

paper The primary endpoint was met, with an overall response rate of 95% (n=63; 95% CI, 87·3-99·1; one-sided p<0·0001). PMID 41692020 ↗

paper Primary/key secondary endpoints were met. PMID 38830991 ↗

release “TRANSCEND FL trial evaluating Breyanzi ® (lisocabtagene maraleucel) in adult patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma met its primary endpoint” bms.com ↗

Publications

• Ahmed S, Martin Garcia-Sancho A, Reguera-Ortega JL, Cartron G, Rapoport AP, Izutsu K, Ghesquieres H, Goto H, Palomba ML, Abramson JS, Borchmann P, Jaeger U, Kamdar M, Dreyling M, Subklewe M, Dahiya S, Nastoupil LJ, Bar M, Strocchia M, Raggi M, Moro Bueno L, Papuga J, Colicino S, Morschhauser F. Durable efficacy and manageable long-term safety of lisocabtagene maraleucel in 3L+ FL: 3-year update from TRANSCEND FL. Blood. 2026 Jul 1:blood.2026034327. doi: 10.1182/blood.2026034327. Online ahead of print.
• Palomba ML, Schuster SJ, Karmali R, Skarbnik AP, Abramson JS, Ardeshna K, Borchmann P, Hill BT, Garcia-Sancho AM, Marcacci G, Rapoport AP, Cartron G, Fleury I, Izutsu K, Kamdar M, Mielke S, Barbui AM, Ortega JLR, Nastoupil LJ, Ahmed S, Bar M, Diaz L, Furustrand U, Diab V, Vedal M, Avilion A, Kumar J, Nishii R, Colicino S, Morschhauser F. Lisocabtagene maraleucel in patients with relapsed or refractory marginal zone lymphoma (TRANSCEND FL): primary analysis results from the global, multicohort, single-arm, phase 2 study. Lancet. 2026 Mar 7;407(10532):963-975. doi: 10.1016/S0140-6736(25)02435-3. Epub 2026 Feb 12.
• Morschhauser F, Dahiya S, Palomba ML, Martin Garcia-Sancho A, Reguera Ortega JL, Kuruvilla J, Jager U, Cartron G, Izutsu K, Dreyling M, Kahl B, Ghesquieres H, Ardeshna K, Goto H, Barbui AM, Abramson JS, Borchmann P, Fleury I, Mielke S, Skarbnik A, de Vos S, Kamdar M, Karmali R, Viardot A, Farazi T, Fasan O, Lymp J, Vedal M, Nishii R, Avilion A, Papuga J, Kumar J, Nastoupil LJ. Lisocabtagene maraleucel in follicular lymphoma: the phase 2 TRANSCEND FL study. Nat Med. 2024 Aug;30(8):2199-2207. doi: 10.1038/s41591-024-02986-9. Epub 2024 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lisocabtagene Maraleucel	Cell therapy	1e+08 cells	—
Background	Cyclophosphamide	Other / unclassified	300 mg/m2	Intravenous
Background	Fludarabine	Small molecule	30 mg/m2	Intravenous

Indications