What side effects are associated with this type of intervention?

Common treatments for Non-Hodgkin's Lymphoma, particularly CAR-T cell therapies like those targeting CD19, can cause cytokine release syndrome (CRS), leading to fever, hypotension, and respiratory distress. Neurological toxicities such as confusion, seizures, and encephalopathy are also frequent. Additional side effects include cytopenias, increased risk of infections, and potential organ toxicities. These side effects necessitate vigilant monitoring and management.

What prior FDA approvals exist?

The FDA has approved several treatments for Non-Hodgkin's Lymphoma, including various CAR-T cell therapies. Notably, CD19-directed CAR-T cell therapies such as axicabtagene ciloleucel (Yescarta) and tisagenlecleucel (Kymriah) have shown significant efficacy in treating relapsed or refractory NHL. These therapies work by modifying a patient's T cells to target and kill lymphoma cells expressing the CD19 antigen. While BAFF-targeting CAR-T cells are still under investigation, these CD19-targeted therapies represent a similar approach in harnessing the immune system to combat lymphoma.

What other types of research exist?

Promising novel alternatives to BAFF CAR-T cells for Non-Hodgkin's Lymphoma patients include: 1) CD19-targeted CAR-T cell therapies, which have shown durable responses in B-cell malignancies; 2) Anti-BCMA CAR-T cell therapy, such as bb2121, which has demonstrated efficacy in multiple myeloma and may be applicable to NHL; 3) Bispecific T-cell engagers (BiTEs) like AMG 420, targeting B-cell maturation antigen (BCMA); 4) Antibody-drug conjugates like GSK2857916, targeting BCMA; and 5) Immune checkpoint inhibitors, such as anti-PD-1 or anti-PD-L1 therapies, which have shown promise in various lymphomas.

← Back to Search

CAR T-cell Therapy

BAFF CAR-T for Non-Hodgkin Lymphoma

Phase 1

Recruiting

Led By Paolo F. Caimi, MD

Research Sponsored by Luminary Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adequate pulmonary function as defined as pulse oximetry ≥ 92% on room air

Cardiac ejection fraction of >50%, and no evidence of pericardial effusion, as determined by an echocardiogram

Must not have

History of allogeneic hematopoietic stem cell transplantation

Active malignancy, other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new immune cell therapy for patients with non-Hodgkin lymphoma who haven't responded to other treatments. The therapy involves modifying the patient's own immune cells to better recognize and attack their cancer.

Who is the study for?

Adults over 18 with non-Hodgkin lymphoma that's come back after at least two treatments or hasn't responded to chemo can join. They need good liver, kidney, heart, and lung function, no brain lymphoma, and must use effective birth control. Those who've had recent other cancer treatments or have certain health issues like severe heart problems or active infections can't participate.

What is being tested?

The trial is testing a new therapy called BAFF CAR-T cells for people whose non-Hodgkin lymphoma didn't respond to previous treatments including CD19 targeted CAR-T cells. It aims to find the safest dose of BAFF CAR-T and see how well it works against the disease.

What are the potential side effects?

Potential side effects may include immune system reactions affecting different parts of the body, symptoms related to infusion such as fever or chills, tiredness, changes in blood counts leading to increased infection risk or bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My oxygen level is 92% or higher without extra oxygen.

Select...

My heart pumps well and I don't have fluid around it.

Select...

My non-Hodgkin lymphoma has returned after 2+ treatments or is resistant to chemotherapy.

Select...

I can take care of myself but might not be able to do heavy physical work.

Select...

I do not have lymphoma in my brain or spinal cord.

Select...

I agree to either not have sex or use birth control, and not donate sperm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a stem cell transplant from a donor.

Select...

I have an active cancer other than non-dangerous skin cancer or early-stage cancers.

Select...

I have the most severe form of heart failure.

Select...

I have had a stem cell transplant within the last 6 weeks.

Select...

I am experiencing symptoms of graft-versus-host disease.

Select...

My lymphoma or leukemia has spread to my brain or spinal cord.

Select...

I am HIV positive.

Select...

I am currently receiving IV treatment for an infection.

Select...

I do not have a history of significant brain-related health issues like epilepsy or severe brain injuries.

Select...

I have another cancer that needs treatment through the bloodstream.

Select...

My tests show early signs of a bone marrow disorder before starting treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine recommended phase II dose of human LMY-920.

Secondary study objectives

To determine incidence of adverse events.

To determine incidence of anti- LMY-920 antibodies.

To determine the complete response rate.

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LMY-920 dose escalationExperimental Treatment1 Intervention

Open label, dose escalation study with up to four dose levels of LMY-920. The maximum tolerated dose (MTD) of LMY-920 will be determined using dose-escalation 3+3 design.

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Hodgkin's Lymphoma (NHL) include CAR-T cell therapy, monoclonal antibodies, and small molecule inhibitors. CAR-T cell therapy involves modifying a patient's T cells to express chimeric antigen receptors (CARs) that specifically target and kill lymphoma cells. Monoclonal antibodies, such as rituximab, target specific proteins on the surface of lymphoma cells, leading to their destruction. Small molecule inhibitors, like ibrutinib, block signaling pathways essential for lymphoma cell survival and proliferation. The BAFF CAR-T cells being studied aim to target the BAFF receptor on lymphoma cells, offering a novel approach to treatment. These targeted therapies are crucial for NHL patients as they provide more precise and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.