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CAR T-cell Therapy

CAR T-Cell Therapy for Lung Cancer

Phase < 1
Recruiting
Led By Jared Weiss
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has demonstrated adequate organ function
Subject must be platinum-refractory and either currently receiving or has previously received a PD1/PDL1 inhibitor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a combination of antibodies and T cells to treat lung cancer. It will look at how much of the treatment is safe and what dosage is the most effective.

Who is the study for?
This trial is for adults with advanced lung cancer that's resistant to platinum chemotherapy and has been treated with PD-1/PD-L1 inhibitors. Participants must be in good enough health, have a life expectancy of at least 12 weeks, and women able to have children need a negative pregnancy test before cell collection.Check my eligibility
What is being tested?
The study tests autologous T lymphocyte chimeric antigen receptor cells targeting GD2 (iC9.GD2.CAR.IL-15 T cells). It aims to find the safe dosage levels of these modified immune cells designed to fight lung cancer more effectively than antibodies or T cells alone.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system such as fever, fatigue, and flu-like symptoms; risk of infection; possible organ inflammation due to an overactive immune response; and infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs are functioning well.
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I have cancer that did not respond to platinum-based treatment and have been treated with a PD1/PDL1 inhibitor.
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I am taking less than 10 mg of prednisone daily or its equivalent.
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I am a woman who can have children and have a negative pregnancy test taken within the last 3 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cytokine Release Syndrome (CRS)
Neurotoxicity
Number of participants with adverse event
Secondary outcome measures
Disialoganglioside (GD2) Expression
Neoplasms
Duration of Benefit
+5 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: iC9.GD2.CAR.IL-15 T TherapyExperimental Treatment1 Intervention
Experimental: Single Arm Subjects with extensive stage lung cancer or stage IV non-small cell lung cancer that is platinum-refractory and received PD-1 and/or PD-L1 therapy will receive iC9.GD2.CAR.IL-15 T cells were manufactured from their collected blood sample.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
861 Previous Clinical Trials
227,170 Total Patients Enrolled
UNC Lineberger Comprehensive Cancer CenterLead Sponsor
351 Previous Clinical Trials
88,308 Total Patients Enrolled
Bellicum PharmaceuticalsIndustry Sponsor
27 Previous Clinical Trials
1,328 Total Patients Enrolled

Media Library

iC9.GD2.CAR.IL-15 T cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05620342 — Phase < 1
Non-Small Cell Lung Cancer Research Study Groups: iC9.GD2.CAR.IL-15 T Therapy
Non-Small Cell Lung Cancer Clinical Trial 2023: iC9.GD2.CAR.IL-15 T cells Highlights & Side Effects. Trial Name: NCT05620342 — Phase < 1
iC9.GD2.CAR.IL-15 T cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05620342 — Phase < 1

Frequently Asked Questions

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

What is the fundamental aim of this clinical study?

"This medical trial is assessing cytokine release syndrome (CRS) for a time frame of up to 4 weeks. Secondary outcomes in this study include disialoganglioside expression, overall response rate and duration of response which will be measured using immunohistochemistry on tumor samples collected from participants according to Response Evaluation Criteria In Solid Tumors criteria. ORR is calculated by summing the number of patients that achieved complete or partial responses divided by the total number who received treatment while DOR is noted as starting with either partial or full respose to disease progression based on RECIST 1.1 metrics: CR defined as disappearance"

Answered by AI

Are patients being recruited for this experiment currently?

"According to clinicaltrials.gov, this medical experiment is no longer enrolling candidates. It was initially listed on January 15th 2023 and its most recent update occurred in November 16th 2022. Nevertheless, 1979 other trials are actively recruiting patients at the present time."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
~13 spots leftby Feb 2025