Lisocabtagene Maraleucel for Lymphoma

Recruiting at 45 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 2

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

Must be taking: High-dose methotrexate

Must not be taking: Immunosuppressive therapy

Disqualifiers: Secondary CNS lymphoma, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

65 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called lisocabtagene maraleucel, a type of cell therapy, for individuals with Primary Central Nervous System Lymphoma (PCNSL). The researchers aim to assess the safety and effectiveness of this treatment for those ineligible for a transplant. Participants should have previously tried standard treatments and responded well to high-dose methotrexate, a potent cancer drug. This trial may suit individuals whose PCNSL has mostly receded with prior treatments but who still require a new treatment option. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that prior anti-cancer therapy should only include standard regimens with or without corticosteroids. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that lisocabtagene maraleucel is likely to be safe for humans?

Research has shown that lisocabtagene maraleucel, or liso-cel, is generally safe. In one study, patients who received liso-cel experienced no new safety issues over three years. Another study found that a single dose of liso-cel was effective and safe over time, indicating that most patients tolerated the treatment well.

Liso-cel already has FDA approval for other uses, which supports its safety profile. However, each trial is unique, so it's important to consider the specific details. For those considering joining a trial, these studies suggest that liso-cel has been safely used by many people before. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Lisocabtagene maraleucel, or Liso-cel, is unique because it is a CAR T-cell therapy specifically designed to target and destroy lymphoma cells. Unlike traditional chemotherapy and radiation, which can harm healthy cells, Liso-cel uses genetically modified T-cells that are programmed to identify and attack cancer cells. This precision approach not only has the potential to be more effective but also aims to reduce the severe side effects often associated with conventional treatments. Researchers are excited about Liso-cel because it represents a shift towards more personalized and targeted cancer therapies, offering hope for improved outcomes in patients with lymphoma.

What evidence suggests that lisocabtagene maraleucel might be an effective treatment for lymphoma?

Research has shown that lisocabtagene maraleucel, the treatment under study in this trial, effectively treats certain types of lymphoma. In one study, 84% of patients responded to the treatment, with their cancer shrinking or disappearing. Additionally, 68% of patients achieved complete remission, with no signs of cancer detected. Lisocabtagene maraleucel proved more effective and longer-lasting than standard treatments over three years, maintaining a good safety record. These findings suggest strong potential for this treatment in addressing lymphoma, including Primary Central Nervous System Lymphoma (PCNSL). ^{1 2 3 6 7}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with a type of brain lymphoma called Primary Central Nervous System Lymphoma who can't undergo transplant. Participants should be receiving their first treatment.

Inclusion Criteria

I am 18 years old or older.

My diagnosis of brain lymphoma is confirmed by a biopsy.

I have only received standard treatments for my brain lymphoma, possibly with steroids for symptoms.

Exclusion Criteria

Other protocol-defined Inclusion/Exclusion criteria apply

I am on medication for an autoimmune disease.

My cancer is in the eye or the fluid around my brain and spine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lisocabtagene maraleucel (liso-cel) as first-line therapy for PCNSL

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Long-term follow-up

Participants are monitored for overall survival and quality of life

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• Lisocabtagene Maraleucel

Trial Overview The study tests the safety and effectiveness of a therapy named Lisocabtagene Maraleucel (Liso-cel) as an initial treatment, comparing it with other standard drugs like Temozolomide and Rituximab.

How Is the Trial Designed?

Group I: Liso-cel Administration Experimental Treatment 8 Interventions

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

19

Recruited

3,100+

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/470/531306/Real-World-RW-Outcomes-of-Lisocabtagene-Maraleucel

Real-World (RW) Outcomes of Lisocabtagene Maraleucel (liso ... At a median (range) follow-up of 6.2 mo (0.3-13.8), ORR and CR rate (95% CI) in the overall cohort were 84% (77-90) and 68% (59-76), respectively.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40623279/

Lisocabtagene Maraleucel Versus Standard of Care for ... At 3-year follow-up, liso-cel confirmed superior, more durable efficacy versus SOC with a favorable safety profile and no new safety signals.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00399

Lisocabtagene Maraleucel Versus Standard of Care for ... At 3-year follow-up, liso-cel confirmed superior, more durable efficacy versus SOC with a favorable safety profile and no new safety signals.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666636725003768

308 Outcomes of Standard of Care (SOC) Lisocabtagene ... Effectiveness outcomes included ORR, CR rate, duration of response (DOR), PFS, and OS. Safety outcomes included cytokine release syndrome (CRS), immune effector ...

5. haematologica.org haematologica.org/article/view/haematol.2024.285828

Comparative efficacy of lisocabtagene maraleucel in the ... This study assessed the comparative efficacy of lisocabtagene maraleucel (liso-cel) in the open-label, phase II PILOT study (clinicaltrials.gov NCT 03483103)

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666636725003574

Effectiveness and Safety Outcomes of Standard of Care ... In this large, multicenter, observational study, 1-time infusion of liso-cel was effective with deep, durable responses in pts with R/R tLBCL. Safety remained ...

7. news.bms.com news.bms.com/news/details/2025/Bristol-Myers-Squibb-Presents-First-Data-from-the-Marginal-Zone-Lymphoma-Cohort-of-the-Transcend-FL-Trial-Demonstrating-Deep-and-Durable-Responses-with-Breyanzi-lisocabtagene-maraleucel/default.aspx

Corporate news details 95.5% of patients with relapsed or refractory marginal zone lymphoma (MZL) treated with lisocabtagene maraleucel (liso-cel) achieved a response.