Recruiting

Lisocabtagene Maraleucel

Sponsor:

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

Code:

NCT06788652

Conditions

Mantle Cell Lymphoma (MCL)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lisocabtagene maraleucel

Study Details

Brief summary:

The purpose of this study is to understand the long-term safety and effectiveness of lisocabtagene maraleucel (liso-cel) for the treatment of Mantle Cell Lymphoma (MCL).

Conditions

Mantle Cell Lymphoma (MCL)

Study ID

NCT06788652

Start date

Feb 4, 2025

Status verified date

Feb, 2025

Completion date

Sep 30, 2044

Anticipated

Primary completion date

Sep 30, 2044

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

• Participants must have been treated in the postmarketing setting with at least 1 infusion of lisocabtagene maraleucel (Liso-cel) used for the treatment of Mantle Cell Lymphoma (MCL) according to the FDA-approved indication and dose range (ie, per the US Prescribing Information) and with a product meeting the specifications for commercial release approved in the USA

Exclusion Criteria:

  • Participants known to be participating in investigational studies at the time of liso-cel infusion.
  • Participants treated with non-conforming CAR T-cell product.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants treated with lisocabtagene maraleucel

Interventions

Lisocabtagene maraleucel

According to US Prescribing Information

Primary outcome measure

  • Adverse events (AEs) [ 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

Center for International Blood and Marrow Transplant Research (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

  • Mantle Cell Lymphoma (MCL)

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.