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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 must be platinum-refractory and either currently receiving or has previously received a PD1/PDL1 inhibitor

Be older than 18 years old

Must not have

Subject does not have adequate organ function

Subject did not receive platinum-based chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I have cancer that did not respond to platinum-based treatment and have been treated with a PD1/PDL1 inhibitor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My organs are not functioning properly.

Select...

I have not had platinum-based chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cytokine Release Syndrome (CRS)

Neurotoxicity

Number of participants with adverse event

Secondary study objectives

Disialoganglioside (GD2) Expression

Neoplasms

Duration of Benefit

+5 more

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: 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.

0 / 3Eligibility criteria met