What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies like gefitinib and immunotherapies such as anti-PD-1/PD-L1 agents. Gefitinib is associated with side effects like skin rashes and diarrhea, which are generally well tolerated. Immunotherapies, including anti-PD-1/PD-L1 agents, can cause fatigue, nausea, increased liver function tests, and immune-related adverse events such as pneumonitis, rash, and pruritus. For KRAS-mutant NSCLC, treatments like sotorasib and adagrasib may cause fatigue, nausea, and liver function abnormalities. These side effects are important considerations when evaluating treatment options with a healthcare provider.

What prior FDA approvals exist?

For the treatment of Non-Small Cell Lung Cancer (NSCLC), the FDA has approved several targeted therapies for specific genetic mutations. For instance, sotorasib and adagrasib are approved for NSCLC with the KRAS G12C mutation. Additionally, therapies targeting other genetic alterations include osimertinib for EGFR mutations, crizotinib for ALK rearrangements, and larotrectinib or entrectinib for NTRK fusions. These approvals highlight the trend towards personalized, genotype-directed therapy in NSCLC, similar to the approach being studied with NT-112 for KRAS G12D mutations.

What other types of research exist?

Promising novel alternatives to NT-112 for NSCLC patients include: 1) Tislelizumab, an anti-PD-1 inhibitor, which has shown improved progression-free survival (PFS) and overall response rates (ORRs) when combined with chemotherapy. 2) Sintilimab, another anti-PD-1 antibody, which has demonstrated improved PFS in combination with chemotherapy for both squamous and nonsquamous NSCLC. 3) Durvalumab plus Tremelimumab, particularly for patients with high tumor mutational burden (TMB), which has shown improved overall survival (OS) in post-hoc analyses.

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CAR T-cell Therapy

NT-112 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Neogene Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Subject has advanced solid cancer, defined as unresectable, advanced, and/or metastatic disease (Stage III or IV) after at least 1 line of approved systemic standard of care (SOC) treatment regimen and for which there are no available curative treatment options

Age ≥18 years

Must not have

History of prior adoptive cell and gene therapy, allogeneic stem cell transplant or solid organ transplantation

Known, active primary central nervous system (CNS) malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post-infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial tests NT-112, a personalized immune cell treatment, in patients with advanced cancers that have a specific genetic mutation. The treatment boosts the patient's immune cells to target and kill cancer cells. This highly personalized cancer therapy involves giving the patient immune cells that directly attack cancer.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors like lung, colorectal, pancreatic or endometrial cancer that can't be surgically removed and have worsened despite treatment. Participants must have a specific genetic feature (KRAS G12D mutation) and a certain immune system marker (HLA-C*08:02). They should be relatively well-functioning (ECOG status of 0-1).

What is being tested?

The study tests NT-112, which are T cells from the patient's own body engineered to target cancer cells with the KRAS G12D mutation. It's an early-phase trial to see how safe it is and how well it works against these tough-to-treat cancers.

What are the potential side effects?

While not explicitly listed in your information provided, similar therapies often cause flu-like symptoms, fatigue, fever, chills, weakness and risk of infection. Some may experience severe immune reactions.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is advanced and cannot be surgically removed, and I've tried at least one standard treatment.

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I am 18 years old or older.

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My tumor has a KRAS G12D mutation and I am HLA-C*08:02 positive.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I have had cell, gene, or organ transplant therapy before.

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I have an active brain cancer diagnosis.

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I have not had serious heart problems or heart failure in the last 6 months.

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I haven't had any systemic therapy for my condition in the last 2 weeks or 3 half-lives, whichever is shorter.

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I am currently breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months post-infusion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Adverse events and Serious adverse events

Evaluate the safety of NT-112 in subjects with unresectable, advanced, and/or metastatic solid tumors; evaluation of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D(s))

Secondary study objectives

Preliminary anti-tumor activity of NT-112 in subjects with unresectable, advanced, and/or metastatic solid tumors

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: NT-112Experimental Treatment1 Intervention

Dose Escalation of NT-112.

0 / 9Eligibility 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-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and chemotherapy. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), specifically inhibit cancer cell growth by targeting genetic mutations like EGFR, ALK, and KRAS. Immunotherapies, including checkpoint inhibitors like anti-PD-1 and anti-CTLA-4, enhance the immune system's ability to recognize and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells. For NSCLC patients, especially those with specific mutations like KRAS G12D, these treatments offer personalized and potentially more effective options. The NT-112 trial, which involves genetically engineered T-cells targeting the KRAS G12D mutation, represents an advanced approach in targeted therapy, aiming to improve outcomes by directly attacking cancer cells with precision.