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CAR T-cell Therapy

GT103 for Non-Small Cell Lung Cancer

Phase 1
Waitlist Available
Led By Jeffrey Clarke, MD
Research Sponsored by Edward Patz
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically and/or cytologically confirmed advanced stage III, IV or recurrent NSCLC whose tumors have progressed on prior therapy
Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and prior to treatment on Cycle 1 Day 1; both men and women must be willing to use two medically accepted methods of contraception, one of them being a barrier method during the study and for 6 months after last study drug administration
Must not have
Symptomatic brain or leptomeningeal metastases, including patients who continue to require glucocorticoids and/or antiseizure therapy for brain or leptomeningeal metastases
Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see what dose is safe and effective.

Who is the study for?
Adults over 18 with advanced stage III, IV or recurrent NSCLC that's worsened after prior therapy can join. They must have measurable disease, acceptable organ function, and no severe allergies to PD-1/PD-L1 drugs. Participants need a stable ECOG status (0 or 1), adequate bone marrow function, and must use effective contraception.
What is being tested?
The trial is testing GT103's highest dose patients can tolerate while checking its safety and effectiveness against advanced non-small cell lung cancer. It involves people whose cancer has progressed despite previous treatments.
What are the potential side effects?
While the specific side effects of GT103 are not listed here, similar drugs often cause immune-related reactions, fatigue, nausea, liver inflammation, skin rash and potential infusion-related symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced lung cancer has worsened after previous treatment.
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I am not pregnant and agree to use two forms of birth control, including a barrier method, during and for 6 months after the study.
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I have EGFR, ALK, or ROS1 cancer mutations and have been treated with a TKI and platinum-based chemotherapy.
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My kidneys work well enough, with a creatinine clearance of 50 cc/min or more.
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I am 18 years old or older.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need medication for brain-related cancer symptoms.
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I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.
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My heart often beats faster than 100 beats per minute.
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I have been diagnosed with HIV/AIDS.
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I've had a bad reaction to specific cancer immunotherapy drugs.
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I have an autoimmune disease but only take 10 mg or less of prednisone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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
Recommended phase II dose (RP2D) of GT103
To determine the maximum tolerated dose (MTD), if any
Secondary study objectives
Overall Survival
Progression-Free Survival
Response Rate

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: GT103Experimental Treatment1 Intervention
Participants will receive GT103 every 3 weeks. GT103 will be escalated from .3mg/kg up 10 to mg/kg or until MTD is found

Find a Location

Who is running the clinical trial?

Edward PatzLead Sponsor
Jeffrey Clarke, MDPrincipal InvestigatorDuke University
4 Previous Clinical Trials
49 Total Patients Enrolled

Media Library

GT103 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04314089 — Phase 1
Lung Cancer Research Study Groups: GT103
Lung Cancer Clinical Trial 2023: GT103 Highlights & Side Effects. Trial Name: NCT04314089 — Phase 1
GT103 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04314089 — Phase 1
~6 spots leftby Dec 2025
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