Axatilimab + CAR-T for Lymphoma

JM
CG
Overseen ByCaitlin Guzowski, MBA, MHA, CCRC
Age: Any Age
Sex: Any
Trial Phase: Phase 1
Sponsor: Northside Hospital, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new combination of treatments for individuals with high-risk large B-cell lymphoma, a type of blood cancer. It tests the effectiveness of axatilimab, a drug, combined with CAR-T cell therapy, which uses specially modified cells to fight cancer. Individuals diagnosed with large B-cell lymphoma who meet specific health criteria, such as eligibility for CAR-T therapy, may be suitable candidates for this trial. The goal is to determine if this combination can better manage or reduce the cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that axatilimab is generally well-tolerated by patients. Previous studies found that while some side effects occurred, they were manageable. The FDA has approved axatilimab for another condition, suggesting its safety based on use in other contexts.

Regarding CAR-T cell therapy, studies have shown it can be effective, but serious side effects may occur early on. An earlier study reported that four patients died within two months of starting the treatment. Awareness of these risks is important, though many patients experienced positive results.

Overall, both treatments have shown promise for good outcomes, but risks must be considered. Trial participants will receive close monitoring to manage any side effects.12345

Why are researchers excited about this trial's treatments?

Axatilimab is unique because it combines with CAR-T cell therapy to target lymphoma in a novel way. Unlike traditional treatments like chemotherapy or radiation, which attack cancer cells broadly and can impact healthy cells, Axatilimab works by inhibiting the CSF-1 receptor, which plays a role in the immune system's regulation. This approach helps enhance the effectiveness of CAR-T therapy, making it potentially more precise and less harmful to healthy tissues. Researchers are excited about this combination because it promises to improve the immune system's ability to fight cancer more effectively and with fewer side effects.

What evidence suggests that this trial's treatments could be effective for high-risk lymphoma?

Research shows that combining Axatilimab with CAR T-cell therapy, as studied in this trial, may offer promise for treating high-risk lymphoma. In earlier studies, CAR T-cell therapy alone achieved a success rate of up to 89%, with some patients experiencing complete remission, meaning their cancer disappeared. After two years, 62.3% of patients did not see their disease progress. This trial combines Axatilimab with CAR T-cell therapy to potentially enhance these outcomes by targeting specific parts of the lymphoma. Although the long-term effectiveness of this combination is still under study, early results suggest it could be a strong option for those with hard-to-treat lymphoma.678910

Are You a Good Fit for This Trial?

This trial is for adults (18+) with confirmed large B-cell lymphoma who have high-risk features and are eligible for CAR-T therapy. Participants must have measurable disease, good heart, liver, lung, and kidney function.

Inclusion Criteria

I am 18 years old or older.
Calculated or measured creatinine Clearance ≥ 30 mL/min
ALT/AST < 5x ULN
See 8 more

Exclusion Criteria

I currently have hepatitis B or C infection.
I am unable to care for myself and need help with daily activities.
I have not had another aggressive cancer in the past 3 years.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive axatilimab in combination with CAR T cell therapy, following a fast-track dose escalation design

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple timepoints

1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Axatilimab

Trial Overview

The study tests the combination of Axatilimab (an antibody drug) with CAR-T cell therapy in people with high-risk lymphoma to see if this approach works better than standard treatments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Axatilimab + Commercial CAR T cell therapyExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northside Hospital, Inc.

Lead Sponsor

Trials
26
Recruited
1,100+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38631712/

Combinational therapy of CAR T-cell and HDT/ASCT ...

The 2-year progression-free survival rate was 62.3%, and the overall survival was 68.5% after a median follow-up of 27.0 months. No unexpected ...

Significant Progress in CAR T-Cell Therapy for Difficult-to ...

Long-term data showed an overall response rate (ORR) of 53.0%, with 39% of patients having a complete response (CR) as their best overall ...

From Axatilimab to Zanubrutinib: Treatment Updates Abound

Two years after treatment, 27.8% of patients treated with ASCT experienced another relapse compared with 48% of those treated with CAR T-cell ...

Outcomes after anti-CD19 CAR T-cell therapy in primary ...

outcomes were favorable with durable disease control. The two-year overall survival was 75.5% and the progression-free survival 58%. ...

Real-World Outcomes of Anti-CD19 Chimeric Antigen ...

Best overall and complete response rates were 74.4% (95% CI, 64.9 to 83.8) and 67.1% CAR T-cell therapy was well tolerated, with 58 patients ( ...

CAR T-Cell Therapies Drive Outcomes in Lymphoma ...

In terms of safety, no new deaths related to the therapy occurred. Early in the study, four patients died within two months of treatment

1 Safety and Efficacy of Axatilimab at 3 Different Doses in ...

Safety endpoints included frequency and severity of treatment-related adverse events (TRAEs) and treatment-emergent adverse events (TEAEs).

Axatilimab + CAR-T for Lymphoma · Info for Participants

Axatilimab will have tolerable side effects. Participants must have measurable disease, good heart, liver, lung, and kidney function. are monitored for safety ...

9.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35934632/

Impact of Chronic Kidney Disease and Acute Kidney Injury ...

AKI after CAR-T showed no impact on post procedure OS. The median OS was 10 and 7 months were associated with an increased risk of developing AKI. Conclusions: ...

Real-World Data for CAR T-Cell Therapy for R/R DLBCL

There were patients who survived, and a majority of patients did well and will likely be cured from these therapies. the median progression- ...