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CAR T-cell Therapy

NT-112 for Non-Small Cell Lung Cancer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months post-infusion

Awards & highlights

Study Summary

This trial is testing a new treatment called NT-112, which involves using a person's own T-cells that have been genetically modified to target a specific mutation found in certain types of 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).Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: NT-112Experimental Treatment1 Intervention

Dose Escalation of NT-112.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Neogene Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

24 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants involved in this clinical investigation?

"Indeed, as per the details on clinicaltrials.gov, this research investigation is actively seeking suitable candidates. The trial was first made available for enrollment on February 15th, 2024 and underwent its latest update on February 5th, 2024. Enrollment involves recruiting a total of 24 individuals from one designated site."

Answered by AI

Are there any ongoing opportunities for patients to enroll in this clinical trial?

"As outlined on clinicaltrials.gov, this trial is presently in search of eligible participants. Its initial posting was on February 15th, 2024, with the most recent update made on February 5th of the same year."

Answered by AI

What are the safety considerations associated with NT-112 for individuals?

"The safety rating of NT-112 from our team at Power is graded as 1 due to its Phase 1 trial status, suggesting scarce evidence backing its safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metastatic Solid Tumors Positive for the KRAS G12D Mutation

2024. "A Study of NT-112 in HLA-C*08:02-Positive Adult Subjects With Unresectable, Advanced, and/ or Metastatic Solid Tumors Positive for the KRAS G12D Mutation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06218914.

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