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CAR T-cell Therapy
Engineered T-Cell Therapy for 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months post-infusion
Awards & highlights
Study Summary
This trial tests a new therapy to treat solid tumors with a mutated gene. It uses a patient's own cells to treat their cancer.
Who is the study for?
Adults over 18 with advanced solid tumors positive for HLA-A*02:01 and TP53 R175H mutation, who've tried standard treatments without cure. Eligible cancers include NSCLC, colorectal adenocarcinoma, head and neck squamous cell carcinoma, pancreatic adenocarcinoma, breast cancer or other solid tumors. Must have measurable disease and be in good physical condition.Check my eligibility
What is being tested?
The trial is testing NT-175 T cells engineered to target the TP53 R175H mutation in various advanced solid tumors. It's a Phase I study assessing safety and how well these modified T cells work against the cancer.See study design
What are the potential side effects?
Potential side effects are not specified but may include immune reactions due to engineered T cells targeting cancer mutations, as well as typical risks associated with immunotherapies such as inflammation or tissue damage at tumor sites.
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
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
Safety of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors
Secondary outcome measures
Preliminary anti-tumor activity of NT-175 in subjects with unresectable, advanced, and/or metastatic solid tumors
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose EscalationExperimental Treatment1 Intervention
Dose Escalation of TCR T cell product
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Who is running the clinical trial?
Neogene Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Ying Yan, MDStudy DirectorNeogene Therapeutics
Medical AffairsStudy DirectorNeogene Therapeutics
39 Previous Clinical Trials
8,536 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had serious heart problems or heart failure in the last 6 months.I have Li-Fraumeni syndrome or a relative diagnosed with it.I have been diagnosed with a specific type of cancer, such as lung, colon, head and neck, pancreatic, breast, or another solid tumor.I haven't had any systemic therapy for at least 2 weeks or 3 half-lives, whichever is shorter.I am able to understand and sign the consent form.I haven't had any cancer except for certain skin, cervix, bladder, breast, or low-grade prostate cancers in the last 3 years.I have not had a stroke or mini-stroke in the last year.I have had cell, gene, or organ transplant therapy before.I am at least 18 years old and can give consent.My tumor has a specific TP53 mutation and I have a certain HLA type.I have an active brain cancer diagnosis.I am on steroids or other drugs for an immune disease not caused by cancer treatment.My blood, kidney, liver, lung, and heart functions are all within normal ranges.I am currently breastfeeding.I am fully active or restricted in physically strenuous activity but can do light work.I have been diagnosed with a specific type of solid tumor cancer.My tumor has a specific TP53 mutation and I have a certain genetic marker.I have not received a live vaccine in the last 4 weeks and do not plan to before starting treatment.My advanced cancer cannot be surgically removed and has not responded to standard treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Federal Drug Administration given its approval to Dose Escalation?
"Due to the limited evidence regarding safety and efficacy, our team assesses Dose Escalation to be a 1 on a scale of 1-3."
Answered by AI
Are there any open enrollment slots for this research endeavor?
"In accordance with information found on clinicaltrials.gov, this particular medical trial is not accepting applicants at the present time; it was posted initially in August of 2023 and most recently updated in May 17th of same year. However, there are 5315 other trials that require participants right now."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I have had multiple complications during my chemotherapy and hence I am looking for alternative treatment for my condition.
PatientReceived 1 prior treatment
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