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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recommended phase II dose (RP2D) of GT103
Time for the concentration of GT103 to reach half of the level administered
To determine the maximum tolerated dose (MTD), if any
Secondary outcome measures
Overall Survival
Progression-Free Survival
Response Rate
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
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Who is running the clinical trial?
Edward PatzLead Sponsor
Jeffrey Clarke, MDPrincipal InvestigatorDuke University
4 Previous Clinical Trials
78 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major surgery or significant injury in the last 4 weeks and don't expect to need major surgery during the study.I need medication for brain-related cancer symptoms.My advanced lung cancer has worsened after previous treatment.I am not pregnant, breastfeeding, and if capable of having children, I am using effective birth control.My heart often beats faster than 100 beats per minute.I have had lung inflammation due to an autoimmune condition but am not currently on steroids.I have been diagnosed with HIV/AIDS.My liver is functioning within the required limits.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.I have another type of cancer, but it's stable and doesn't need treatment right now.I have EGFR, ALK, or ROS1 cancer mutations and have been treated with a TKI and platinum-based chemotherapy.I am not on long-term steroids or immune-weakening drugs, except for low-dose or specific uses.My Stage III cancer worsened within 6 months after immunotherapy.Your heart's electrical activity takes too long to reset between beats.My kidneys work well enough, with a creatinine clearance of 50 cc/min or more.I've had a bad reaction to specific cancer immunotherapy drugs.I haven't had major blood vessel problems or surgery in the last 6 months.I am willing and able to follow the study's requirements.I am 18 years old or older.I am undergoing radiation therapy for areas outside my brain and started within the last 2 weeks.I haven't had a stroke, heart attack, or serious blood clot in the last 6 months.I have an autoimmune disease but only take 10 mg or less of prednisone.Your disease must be able to be measured using a specific set of criteria called RECIST 1.1.I have had immunotherapy and platinum-based chemotherapy for my condition.I am fully active or can carry out light work.My blood counts meet the required levels for treatment.I haven't taken any cancer treatments, including trial drugs, in the last 2 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: GT103
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.
Is this research program currently recruiting participants?
"Affirmative. Clinicaltrials.gov indicates that this medical examination is enlisting participants, with the original date of posting being June 9th 2020 and most recent update on November 22nd 2022. 24 individuals at 3 centres are needed for enrollment in this trial."
Answered by AI
What risk factors should be considered when utilizing GT103?
"Due to the Phase 1 nature of this medical trial, our team at Power assigned GT103 a score of 1 on the safety scale. This reflects limited evidence for both efficacy and security."
Answered by AI
What is the current participant count for this clinical research effort?
"Affirmative. Clinicaltrials.gov confirms that the trial, which was established on June 9th 2020, is currently recruiting for 24 participants from 3 different medical facilities."
Answered by AI
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