Lung CancerEarly Phase 1NCT05620342

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

A Early Phase 1 study testing iC9.GD2.CAR.IL-15 T Infusion in people with Lung Cancer and Small Cell Lung Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Small Cell Lung Carcinoma, Non Small Cell Lung Cancer
What is being tested?: iC9.GD2.CAR.IL-15 T Infusion
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 21 Jun 2023to 24 Oct 2029
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

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

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.

Conditions: Lung Cancer, Small Cell Lung Carcinoma, Non Small Cell Lung Cancer
Being tested: iC9.GD2.CAR.IL-15 T Infusion
Keywords: cellular therapy
Medical subject headings: Lung Neoplasms, Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iC9.GD2.CAR.IL-15 T InfusionBiological
iC9-GD2.CAR.IL-15 T-cells product will be administered via intravenous injection over 5 - 10 minutes.

Study groups in NCT05620342
Study group	Role	What they receive
iC9.GD2.CAR.IL-15 T Therapy	Experimental	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. Receives: Biological: iC9.GD2.CAR.IL-15 T Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with adverse event
The number of participants with adverse events (AE)s will be reported as a measure of the safety and tolerability of C9.GD2.CAR.IL-15 T. AEs will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Measured: Up to 4 weeks
Cytokine Release Syndrome (CRS)
CRS will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading.
Grade 1 - Mild (Symptomatic Management): Fever ≥38^ o C, No hypotension, No hypoxia, Grade 2 - Moderate (Moderate Intervention): Fever ≥38^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe (Aggressive Intervention): Fever ≥ 38^ o C , Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38^oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation, mechanical ventilation), Grade 5 - Death: Death.
Measured: Up to 4 weeks
Neurotoxicity
Neurotoxicity will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Immune effector cell-associated neurotoxicity syndrome (ICANS) Consensus Grading criteria.
ICANS grading criteria are outlined in the protocol on a scale from 1 (mild) to 4 (critical) based on the Immune Effector Cell-Associated Encephalopathy (ICE) Score. Grade 1:Score: 7-9 (mild impairment), Grade 2:Score: 3-6 (moderate impairment), Grade 3: Score: 0-2 (severe impairment), Grade 4: Score: Subject in critical condition, and/or obtunded and cannot perform an assessment of tasks.
Measured: Up to 4 weeks

Secondary outcomes (8)

Identification of Recommended phase 2 dose (RP2D)
The RP2D of iC9-GD2.CAR.IL-15 T-cells will be determined based on the modified 3+3 dose-finding rule based on the protocol. Dose escalation will be performed considering the dose-limiting toxicities (DLTs), dose level (DL) will be increased unless there is no DLT.
Measured: Up to 4 weeks
Overall Response Rate (ORR)
ORR will be assessed per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) which defines Complete Response (CR) as the disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall Response Rate (ORR) = number of subjects who achieved CR + number of subjects who achieved PR / total number of subjects who received the study treatment.
Measured: Up to 4 weeks
Progression Free Survival (PFS)
PFS will be measured from the first day of lymphodepletion chemotherapy prior to iC9-GD2.CAR.IL-15 T-cell infusion to progression based on RECIST 1.1 criteria or death.
RECIST 1.1 Criteria: Stable Disease (SD): No response or less response than Partial or Progressive and Progressive Disease (PD): A 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 2 years
Overall Survival (OS)
OS will be measured from the first day of lymphodepletion chemotherapy prior to iC9-GD2.CAR.IL-15 T-cell infusion to date of death for any cause.
Measured: Up to 2 years
Duration of Response (DOR)
DOR is defined as the time from documentation of partial response or response to disease progression based on RECIST 1.1.
RECIST 1.1 Criteria: Complete Response (CR) as the disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions. Overall Response Rate (ORR) = number of subjects who achieved CR + number of subjects who achieved PR / total number of subjects who received the study treatment.Stable Disease (SD): No response or less response than Partial or Progressive and Progressive Disease (PD): A 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 2 years
Duration of Benefit
Duration of benefit is defined as the time from the first day of lymphodepletion chemotherapy prior to iC9-GD2.CAR.IL-15 T-cell infusion to disease progression, next therapy, or death.
RECIST 1.1 Criteria Progressive Disease (PD): A 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: Up to 2 years
Disialoganglioside (GD2) Expression
GD2 Expression will be measured via immunohistochemistry (IHC) on tumor samples collected from subjects.
Measured: Baseline
Disialoganglioside Expression and tumor response rate correlations
GD2 value and tumor response rate graded according to RECIST 1.1 relation will be evaluated.
Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 202324 Oct 2029

First posted17 Nov 2022
Study start21 Jun 2023
Primary completion24 Nov 2027 (estimated)
Study completion24 Oct 2029 (estimated)

Why it stopped: interim analysis

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05620342
Sponsor's protocol ID: LCCC2115-ATL
Status last verified: Oct 2026
First submitted: 9 Nov 2022
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Ouyang W, Xu Z, Guan S, Hu Y, Gou X, Liu Z, Guo W, Huang Y, Zhang L, Zhang X, Li T, Yang B. Advancement Opportunities and Endeavor of Innovative Targeted Therapies for Small Cell Lung Cancer. Int J Biol Sci. 2025 Jan 20;21(3):1322-1341. doi: 10.7150/ijbs.105973. eCollection 2025.
PubMed 39897044

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Administration of T Cells Expressing a 2nd Generation GD2 Chimeric Antigen Receptor, IL-15, and iCaspase9 Safety Switch in Subjects With Lung Cancer
ClinicalTrials.gov ID: NCT05620342
Acronym / sponsor ID: LCCC2115-ATL
Conditions: Lung Cancer, Small Cell Lung Carcinoma, Non Small Cell Lung Cancer
Keywords: cellular therapy
Phase: Early Phase 1
Study type: Interventional
Recruitment status: SuspendedReason stopped: interim analysis
Enrolment: 24 participants (estimated)
Lead sponsor: UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: Bellicum Pharmaceuticals, United States Department of Defense, M.D. Anderson Cancer Center
Study start: 21 Jun 2023 (actual)
Primary completion: 24 Nov 2027 (estimated)
Study completion: 24 Oct 2029 (estimated)
First posted: 17 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
iC9.GD2.CAR.IL-15 T Therapy	Experimental	Biological: iC9.GD2.CAR.IL-15 T InfusionExperimental: 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
iC9.GD2.CAR.IL-15 T InfusioniC9-GD2.CAR.IL-15 T-cells product will be administered via intravenous injection over 5 - 10 minutes.	Biological	iC9.GD2.CAR.IL-15 T Therapy

Primary outcome

Number of participants with adverse event
Time frame: Up to 4 weeks
The number of participants with adverse events (AE)s will be reported as a measure of the safety and tolerability of C9.GD2.CAR.IL-15 T. AEs will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
Cytokine Release Syndrome (CRS)
Time frame: Up to 4 weeks
CRS will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild (Symptomatic Management): Fever ≥38^ o C, No hypotension, No hypoxia, Grade 2 - Moderate (Moderate Intervention): Fever ≥38^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe (Aggressive Intervention): Fever ≥ 38^ o C , Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38^oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation, mechanical ventilation), Grade 5 - Death: Death.
Neurotoxicity
Time frame: Up to 4 weeks
Neurotoxicity will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Immune effector cell-associated neurotoxicity syndrome (ICANS) Consensus Grading criteria. ICANS grading criteria are outlined in the protocol on a scale from 1 (mild) to 4 (critical) based on the Immune Effector Cell-Associated Encephalopathy (ICE) Score. Grade 1:Score: 7-9 (mild impairment), Grade 2:Score: 3-6 (moderate impairment), Grade 3: Score: 0-2 (severe impairment), Grade 4: Score: Subject in critical condition, and/or obtunded and cannot perform an assessment of tasks.

8 secondary outcomes

Identification of Recommended phase 2 dose (RP2D)
Time frame: Up to 4 weeks
Overall Response Rate (ORR)
Time frame: Up to 4 weeks
Progression Free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Duration of Benefit
Time frame: Up to 2 years
Disialoganglioside (GD2) Expression
Time frame: Baseline
Disialoganglioside Expression and tumor response rate correlations
Time frame: Up to 2 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Derived from this study: PubMed 39897044Ouyang W, Xu Z, Guan S, Hu Y, Gou X, Liu Z, Guo W, Huang Y, Zhang L, Zhang X, Li T, Yang B. Advancement Opportunities and Endeavor of Innovative Targeted Therapies for Small Cell Lung Cancer. Int J Biol Sci. 2025 Jan 20;21(3):1322-1341. doi: 10.7150/ijbs.105973. eCollection 2025.
University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jared Weiss principal investigator

jared_weiss@med.unc.edu

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing iC9.GD2.CAR.IL-15 T Infusion in people with Lung Cancer and Small Cell Lung Carcinoma, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse event (time frame: Up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05620342, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.