ClinicalTrials.gov record NCT05620342

Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Administration of T Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch in Subjects With Lung Cancer

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhaseEarly phase 1A very early study, usually in a small number of people, to learn how the body handles a treatment. It is not designed to show whether the treatment works.
Age18 years old and older
SexAll
LocationUnited States
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 1, open-label study tests an experimental cell therapy made from a participant's own T cells, modified to target the GD2 antigen and to express IL-15 plus a safety switch. It enrolls adults with extensive-stage lung cancer or stage IV non-small cell lung cancer that is platinum-refractory and who have received PD‑1/PD‑L1 therapy. Participants give blood for cell manufacturing, receive a preparatory (lymphodepletion) chemotherapy regimen, then get a single intravenous infusion of the modified T cells and close safety follow-up.

What it is studying. The study is testing the safety and tolerability of autologous iC9-GD2.CAR.IL-15 T cells and aims to find the recommended Phase 2 dose. It will also collect early measures of tumor response, progression-free and overall survival, and measure GD2 expression on tumor tissue to explore correlations with response.

What the researchers hope to learn. To evaluate safety and adverse events of iC9-GD2.CAR.IL-15 T cells; to identify a recommended Phase 2 dose; to collect early data on tumor response, duration of response, progression-free and overall survival; and to study tumor GD2 expression and its relation to response.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This is a phase 1, single-center, open-label study that enrolls adult 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. The purpose of this study is to test the safety of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the GD2 antigen (iC9-GD2.CAR.IL-15 T cells) in subjects with lung cancer. How much (dose) of the iC9-GD2.CAR.IL-15 T cells are safe to use without causing too many side effects and what is the maximum dose that could be tolerated will be studied. Modified immune cells as an experimental treatment that combines antibodies and T cells will be used. Antibodies are proteins that protect the body from foreign invaders like bacteria. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill viruses and other cells, including tumor cells. Although antibodies and T cells have been used to treat cancer and they both have shown promise, neither alone has been able to cure most patients. This study will combine T cells and antibodies to create a more effective treatment. The treatment that is being researched in this study is called autologous T lymphocyte chimeric antigen receptor cells targeted against the disialoganglioside (GD2) antigen that expresses Interleukin (IL)-15, and the inducible caspase 9 safety switch (iC9). The short name for this treatment is iC9.GD2.CAR.IL-15 T cells therapy is an experimental therapy and has not been approved by the Food and Drug Administration. There are two steps. In the first step, blood will be collected from the subjects to prepare the iC9-GD2.CAR.IL-15 T cells. T cells will be isolated from the blood and modified to make iC9-GD2.CAR.IL-15. In the second step, the iC9-GD2.CAR.IL-15 T cells produced from the subject's own blood will be administered to the subject.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Biological
  • iC9.GD2.CAR.IL-15 T Infusion

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Written informed consent to undergo cell procurement explained to, understood by, and signed by the subject.
  • Subject has a life expectancy of ≥ 12 weeks.
  • Subject must be platinum-refractory and either currently receiving or has previously received a PD1/PDL1 inhibitor
  • Use of systemic corticosteroids at doses ≥10 mg prednisone daily or it's equivalent; those receiving <10 mg daily may be enrolled at the discretion of the investigator.
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to cell procurement.
  • Subject has demonstrated adequate organ function.

Exclusion criteria

  • 1 . Subject has less than 12 weeks of life expectancy.
  • Subject did not receive platinum-based chemotherapy
  • Subject does not have adequate organ function.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

After giving written informed consent, participants will have blood collected so T cells can be isolated and manufactured into the investigational iC9.GD2.CAR.IL-15 T cells. Participants will receive lymphodepletion chemotherapy before treatment, then an intravenous infusion of the manufactured T cells (given over about 5–10 minutes). Tumor samples will be tested for GD2 expression, and participants will be closely monitored for side effects (including cytokine release syndrome and neurotoxicity) with safety follow-up up to about 4 weeks and longer assessments of tumor response and survival for up to 2 years.

How the study is structured. Phase 1, single-group, open-label interventional study. Participants provide blood so researchers can make personalized CAR T cells. Before infusion, participants receive lymphodepletion chemotherapy. The CAR T-cell product is given as a single intravenous infusion (over about 5–10 minutes). Participants undergo close safety monitoring (intensive early monitoring for the first weeks) and longer follow-up, with tumor assessments and other tests over time (some outcomes followed up to 2 years). There is no placebo or comparison group.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Lung Cancer; Small Cell Lung Carcinoma; Non Small Cell Lung Cancer. Does it apply to my diagnosis?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Gaucher disease

Clinical trials64 trials listed for Gaucher diseaseEvery trial the registry lists for Gaucher disease, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Gaucher disease researchLatest monthly update: September 2026. Includes: Platelet release. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jun 21, 2023
Primary completion
Nov 24, 2027 (estimated)
Study completion
Oct 24, 2029 (estimated)
Target enrollment
24 participants (estimated)
Last updated on registry
Feb 5, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
UNC Lineberger Comprehensive Cancer Center
Collaborators
  • Bellicum Pharmaceuticals
  • United States Department of Defense
  • M.D. Anderson Cancer Center

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

phase 1
An early-stage study, usually small, mainly to check safety, side effects and how much of a treatment can be given. Whether it works is not the main question yet.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
chimeric antigen receptor
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
Written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.
corticosteroids
Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
childbearing potential
Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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