Lisocabtagene Maraleucel for Non-Hodgkin's Lymphoma

Overseen By Dai Chihara, MD, PHD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Relapsed disease, CNS lymphoma, HIV, 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 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called lisocabtagene maraleucel, or liso-cel, to determine if it can prevent the return of large B-cell lymphoma, a type of blood cancer, in individuals who have responded well to initial treatment but still show signs of cancer DNA. Liso-cel is a type of CAR T-cell therapy that uses a person's own immune cells to fight cancer. The trial will also assess the safety of this treatment for participants. Individuals who have completed first-line chemotherapy for diffuse large B-cell lymphoma and show detectable cancer DNA might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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

In previous studies, the treatment lisocabtagene maraleucel (liso-cel) has shown promising safety results for certain types of lymphoma. One study found that most patients either felt better or noticed no major changes in their health over time. Specifically, 80-96% of patients had stable or improved conditions by day 180.

Another study found that 54% of patients had a complete response to the treatment, meaning their cancer was no longer detectable. These findings suggest the treatment is effective and generally well-tolerated. While encouraging, it's important to remember that any treatment can have side effects, and individual experiences may vary. Always consult a healthcare provider if considering joining a clinical trial. ^{1 2 3 4}

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 eliminate cancerous B-cells in patients with non-Hodgkin's lymphoma, particularly large B-cell lymphoma (LBCL). Unlike traditional treatments like chemotherapy or radiation, Liso-cel involves engineering a patient's own immune cells to fight the cancer, offering a more personalized and potentially effective approach. Researchers are excited because this treatment harnesses the body's immune system to target cancer cells with precision, which may lead to better outcomes and fewer side effects compared to conventional therapies.

What evidence suggests that lisocabtagene maraleucel might be an effective treatment for non-Hodgkin's lymphoma?

Research has shown that lisocabtagene maraleucel (liso-cel) holds promise for treating large B-cell lymphoma. One study found that 73% of patients responded to the treatment, with 53% achieving a complete response, meaning their cancer was not detectable after treatment. Another study reported similar results, with an 80% overall response rate and 54% achieving a complete response. This therapy uses the patient's own immune cells to target and fight cancer cells, making it a powerful option. The evidence supports liso-cel as a potentially effective treatment to prevent lymphoma recurrence. Participants in this trial will receive liso-cel to further evaluate its effectiveness. ^{1 2 3 5}

Who Is on the Research Team?

Dai Chihara, MD, PHD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with Large B-cell Lymphoma who've had a complete response to first-line therapy but still have detectable lymphoma DNA. They should be fit for leukapheresis and chemotherapy.

Inclusion Criteria

I had a check-up within 8 weeks after finishing my first main cancer treatment.

Detectable MRD after first line treatment by Foresight CLARITY™

I am 18 years old or older.

Exclusion Criteria

Severe allergic or anaphylactic reactions or intolerance to anti-CD20 monoclonal antibody therapy or any bispecific antibody

Lactating or pregnant subjects

Administration of any investigational agent within 28 days of first dose of study drug

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) infusion and are monitored for safety and efficacy

12 weeks

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

40 weeks

Periodic visits for assessment

What Are the Treatments Tested in This Trial?

Interventions

• Lisocabtagene Maraleucel

Trial Overview

The study tests if lisocabtagene maraleucel (liso-cel), a CAR T-cell therapy, can prevent cancer recurrence in patients with minimal residual disease after initial treatment success.

How Is the Trial Designed?

Group I: Liso-cel in patients with LBCL Experimental Treatment 2 Interventions

The treatment period for each participants starts with the day of liso-cel infusion to day 90

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1.

onclive.com

onclive.com/view/liso-cel-data-confirm-durable-efficacy-and-confer-broad-use-in-r-r-lbcl

Liso-Cel Data Confirm Durable Efficacy and Confer Broad ...

The overall response rate was [73%] with [53%] of patients having a complete response [CR], and the median overall survival [OS] in that study ...

2.

ashpublications.org

ashpublications.org/bloodadvances/article/9/15/3694/537055/Lisocabtagene-maraleucel-for-R-R-LBCL-in-patients

Lisocabtagene maraleucel for R/R LBCL in patients not ...

Overall response rate (primary end point) was 80%; 54% achieved complete response. After median on-study follow-up of 18.2 months, median ...

3.

ascopubs.org

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

Lisocabtagene Maraleucel Versus Standard of Care for ...

With a median follow-up of 33.9 months, median (95% CI) event-free survival was 29.5 months (9.5 to not reached [NR]) for liso-cel versus 2.4 ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10905070/

patient-reported outcomes from the PILOT study

In the primary analysis of PILOT at a median study follow-up of 12.3 months, the overall response and complete response (CR) rates were 80% and 54%, ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02631044

NCT02631044 | Study Evaluating the Safety and ...

This is an open-label, multicenter Phase 1 study to determine the safety, pharmacokinetics (PK), and antitumor activity of JCAR017 in adult patients with ...