What side effects are associated with this type of intervention?

Common treatments for Small Cell Lung Cancer (SCLC), such as DLL3-targeted CAR T-cells, can cause cytokine release syndrome (CRS), leading to multiorgan dysfunction and acute kidney injury. Electrolyte abnormalities due to tumor lysis syndrome are also observed. Immune checkpoint inhibitors, another treatment option, can cause inflammation in various organ systems, resulting in conditions like colitis, hepatitis, and nephritis. These side effects necessitate careful monitoring and management.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of Small Cell Lung Cancer (SCLC). Atezolizumab, in combination with carboplatin and etoposide, was the first significant advancement in SCLC treatment in decades, showing improved overall survival and progression-free survival. Similarly, durvalumab combined with platinum-etoposide has also demonstrated enhanced survival outcomes. While these treatments are not CAR T-cell therapies, they represent significant immunotherapeutic advances in SCLC. Currently, there are no FDA-approved CAR T-cell therapies specifically for SCLC, but ongoing studies, such as the DLL3-targeted CAR T-cells, are exploring this promising approach.

What other types of research exist?

Promising, novel alternatives to DLL3-targeted CAR T-cells for Small Cell Lung Cancer patients include immune checkpoint inhibitors such as atezolizumab and durvalumab, which have shown improved survival outcomes when combined with chemotherapy. These therapies represent significant advancements in the treatment of SCLC.

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CAR T-cell Therapy

CAR T-Cell Therapy for Small Cell Lung Cancer

Phase 1

Recruiting

Research Sponsored by Legend Biotech USA Inc

Eligibility Criteria Checklist

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

Must have

Have histologically/cytologically confirmed unresectable small cell lung carcinoma (SCLC), large cell neuroendocrine lung carcinoma (LCNEC), combined SCLC, or combined LCNEC as per WHO 2021 criteria

Have available formalin-fixed, paraffin-embedded tumor specimen in a tissue block or unstained serial slides accompanied by an associated pathology report prior to enrollment. Archival or fresh biopsy tissue is required

Must not have

Previous history of allogeneic hematopoietic stem cell transplantation (HSCT), organ transplant, or in preparation for organ transplant

Known leptomeningeal metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, a minimum of 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests specially modified immune cells in patients with advanced lung cancers. These immune cells are designed to find and destroy cancer cells by targeting a specific protein on them.

Who is the study for?

This trial is for adults with extensive stage small cell lung cancer or large cell neuroendocrine lung cancer who've had prior treatment but didn't respond well, can't tolerate further standard treatments, or chose not to continue them. They must be in relatively good health (ECOG status of 0 or 1), have a life expectancy of at least 4 months, and agree to use effective contraception.

What is being tested?

The study is testing LB2102, a new type of therapy involving T-cells engineered to target DLL3 on cancer cells. It's an early-phase trial designed to find the right dose and assess how safe it is for patients with specific types of lung cancer.

What are the potential side effects?

Potential side effects are not detailed here as this is a first-in-human study; however, similar therapies often cause immune reactions, fatigue, fever, and may affect normal blood counts leading to increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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My lung cancer cannot be removed by surgery and fits specific types.

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I can provide a tissue sample of my tumor for the study.

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I have enough non-mobilized cells available for treatment creation.

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I am fully active or can carry out light work.

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I agree not to donate eggs or sperm for 1 year after my LB2102 infusion.

Exclusion Criteria

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

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I have had or am preparing for a stem cell or organ transplant.

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My cancer has spread to the lining of my brain and spinal cord.

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I haven't had major surgery in the last 4 weeks and don't plan to have any in the next 4 weeks.

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I am receiving treatment for an autoimmune disease.

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I am not allergic to LB2102, dimethyl sulfoxide, fludarabine, cyclophosphamide, or tocilizumab.

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I have previously been treated with DLL3-targeted therapy.

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I have previously received cellular immunotherapy or gene therapy.

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I still have side effects from cancer treatment, except for hair loss.

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I have had lung inflammation from previous cancer immunotherapy.

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My heart condition is not well-managed with medication.

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I have fluid buildup in my abdomen or chest.

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I have a condition that weakens my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, a minimum of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, a minimum of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, a minimum of 2 years 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 characterize the safety and tolerability of LB2102 and determine recommended dose for expansion (RDE)

To further characterize the safety and tolerability of LB2102 with the RDE identified in the dose-escalation and determine the recommended Phase 2 dose (RP2D)

Secondary study objectives

To characterize the pharmacokinetics of LB2102 in blood

To evaluate the immunogenicity of LB2102

To evaluate the preliminary efficacy of LB2102

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: Experimental LB2102Experimental Treatment1 Intervention

DLL3-Directed Chimeric Antigen Receptor T-cells (CAR T)

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 Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and targeted therapies. Chemotherapy, often using etoposide and platinum-based drugs, works by killing rapidly dividing cancer cells. Immunotherapy, such as immune checkpoint inhibitors (e.g., anti-PD-1 or anti-CTLA-4 antibodies), enhances the body's immune response against cancer cells. Targeted therapies, like DLL3-targeted chimeric antigen receptor (CAR) T-cells, involve genetically modifying T-cells to specifically target and kill DLL3-expressing cancer cells, which are commonly found in SCLC. This targeted approach is significant for SCLC patients as it offers a more precise attack on cancer cells, potentially leading to better outcomes and fewer side effects compared to traditional treatments.