Trials / Completed
CompletedNCT03483103
Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy (TRANSCEND-PILOT-017006)
A Phase 2 Study of Lisocabtagene Maraleucel (JCAR017) as Second-Line Therapy in Adult Patients With Aggressive B-cell NHL (017006)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- Juno Therapeutics, a Subsidiary of Celgene · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | lisocabtagene maraleucel | lisocabtagene maraleucel will be administered as a single dose intravenous (IV) injection |
Timeline
- Start date
- 2018-07-27
- Primary completion
- 2021-09-24
- Completion
- 2022-12-01
- First posted
- 2018-03-30
- Last updated
- 2023-12-20
- Results posted
- 2022-12-29
Locations
59 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03483103. Inclusion in this directory is not an endorsement.