Recruiting

Liso-cel

Sponsor:

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Code:

NCT06794268

Conditions

Follicular Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lisocabtagene maraleucel

Study Details

Brief summary:

The purpose of this study is to characterise the long-term safety of lisocabtagene maraleucel, focusing on patients treated in the approved follicular lymphoma (FL) indication, and will be part of post-marketing liso-cel pharmacovigilance activities

Conditions

Follicular Lymphoma

Study ID

NCT06794268

Start date

Feb 4, 2025

Status verified date

Feb, 2025

Completion date

Aug 31, 2044

Anticipated

Primary completion date

Aug 31, 2044

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

• Participants must have been treated in the post-marketing setting with at least 1 infusion of lisocabtagene maraleucel (liso-cel) used for the treatment of relapsed/refractory (R/R) follicular lymphoma (FL), including FL Grade 1, Grade 2 and Grade 3a, within the FDA-approved indication and dosage per the United States Prescribing Information (USPI) and product specifications approved for commercial release in the USA

Exclusion Criteria:

  • Participants known to be participating in investigational studies at the time of liso-cel, infusion
  • Participants treated with liso-cel for the treatment of R/R FL Grade 3b
  • Participants treated with non-conforming chimeric antigen receptor (CAR) T-cell product

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants receiving lisocabtagene maraleucel treatment

Interventions

Lisocabtagene maraleucel

As per product label

Primary outcome measure

  • Incidence of adverse events (AEs) of interest [ Time Frame: Up to 15 years ]
  • Incidence of other adverse events (AEs) of interest [ Time Frame: Up to 15 years ]

Central Contacts and Locations

Central contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

855-907-3286Clinical.Trials@bms.com

Locations

CIBMTR

Recruiting

Milwaukee, Wisconsin, United States, 53226

More Information

Sponsor

Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Last update posted

Feb 24, 2025

Last verified

Feb, 2025

Keywords

  • Follicular Lymphoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company on 2025-02-24.