At a glance
ClinicalIndex Comparison Record- ✓Confirmed relapsed or refractory aggressive B-cell NHL: DLBCL (de novo or transformed from follicular lymphoma), double/triple hit lymphoma (DHL/THL), or follicular lymphoma Grade 3B
- ✓Prior single line of chemoimmunotherapy containing anthracycline and CD20-targeted agent required
- ✓Patient must be ineligible for high-dose chemotherapy and hematopoietic stem cell transplant based on age, performance status, and/or comorbidities
- ✓PET-positive disease required
- ✕CNS-only involvement by malignancy (secondary CNS involvement allowed)
- ✕History of another primary malignancy not in remission for at least 2 years
- ✕Prior CD19-targeted therapy (except prior lisocabtagene maraleucel in this protocol for retreatment)
- ✕Active hepatitis B or C infection at screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)
In Brief
A Phase 2 clinical trial evaluating lisocabtagene maraleucel for Lymphoma, Non-Hodgkin and 3 related conditions. Completed, enrolled 74 participants across 59 sites.
Detailed 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.
Study Details
Timeline
Interventions
lisocabtagene maraleucel will be administered as a single dose intravenous (IV) injection