At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 104 enrolled
Drug / intervention
lisocabtagene maraleucelbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Safety Trial of Lisocabtagene Maraleucel (JCAR017) for Relapsed and Refractory (R/R) B-cell Non-Hodgkin Lymphoma (NHL) in the Outpatient Setting
In Brief
A Phase 2 clinical trial evaluating lisocabtagene maraleucel for Lymphoma, Non-Hodgkin and 9 related conditions. Completed, enrolled 104 participants across 23 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma, Non-Hodgkin, Lymphoma, Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Neoplasms, Neoplasms by Histologic Type, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Disorder
CountriesUnited States
CollaboratorsBristol-Myers Squibb
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartNov 2018
Primary CompletionSep 2023
TodayJul 2026
First PostedNov 16, 2018
Enrollment StartNov 29, 2018
Primary CompletionSep 22, 2023
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.6 years ago
Interventions
lisocabtagene maraleucelbiological
lisocabtagene maraleucel will be administered as single dose intravenous (IV) injection