Metastatic Non Small Cell Lung CancerPhase 1NCT05676749
C-TIL051 in Non-Small Cell Lung Cancer
A Phase 1 study testing C-TIL051 in people with Metastatic Non Small Cell Lung Cancer, run by AbelZeta Inc. at 3 sites in United States.
Trial summary
The goal of this Phase 1 clinical study is test tumor infiltrating lymphocytes (known as C-TIL051) with NKTR-255 and anti-PD1 therapy for subjects with refractory non-small cell lung cancer. The purpose of this study is to: 1. Test the safety and ability for subjects to tolerate the TIL therapy 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non Small Cell Lung Cancer
- What is being tested?
- C-TIL051
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Feb 2024to 30 Dec 2025
- Phase
- 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
- Able to understand and give written informed consent
- Histologically and cytologically confirmed diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC) with adenocarcinoma or squamous histology
- Planned for treatment with an anti-PD1 agent
- Tumor accessible by surgery, previously not irradiated and ≥ 1.5 cm in diameter
- Measurable disease after resection of tumor by RECIST 1.1
- ECOG ≤ 1
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- Expected survival > 6 months
- Adequate organ and marrow function
- ECHO, MUGA or cardiac stress test within past 6 months showing LVEF >50% and without evidence of reversible ischemia
- Pulmonary function tests within past 6 months showing DLCO >50% of predicted
Who cannot join
- Previous treatment with PD1/PDL1 inhibitor for metastatic disease, Immune checkpoint blockade (ICB) given as part of definitive therapy for stage Ib-III disease with surgery or after chemo/radiation is acceptable if last dose of ICB is at least 6 months prior to enrollment in this study.
- Known driver mutations such as EGFR, ALK, ROS1, RET, METex14, and NTRK alterations.
- Current or prior use of any immunosuppressive medications within 14 days before tumor harvest
- Known active CNS metastases which are symptomatic
- History of leptomeningeal metastases
- Uncontrolled intercurrent illness
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- Known history of HIV+ or AIDS, hepatitis C, acute or chronic active hepatitis B or other serious chronic infection
- Live vaccine within 30 days of tumor harvest
- History of allogeneic organ transplant
- History of primary immunodeficiency
- Hypersensitivity to anti-PD1 agent, cyclophosphamide, fludarabine, interleukin-2, gentamicin, or any excipient
- Any condition that may interfere with evaluation of study treatment, safety or study results
- Active infection that requires IV antibiotics within 7 days of tumor harvest
- Unresolved greater than grade 1 toxicity (CTCAE v5.0) from previous therapy
- History of interstitial pneumonitis of autoimmune etiology that is symptomatic or requires treatment
- Pulmonary disease history requiring escalating amounts of oxygen > 2L
- Known autoimmune conditions requiring systemic immune suppression therapy other than low dose prednisone or equivalent.
- Other malignancy, other than cutaneous localized) that required active treatment in the last 2 years.
- Women who are pregnant or lactating
- Women of childbearing potential or fertile men who are unwilling to use effective contraception during study and 6 months after treatment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ochsner MD Anderson Cancer Center
New Orleans, Louisiana, 70121
Allegheny Health Network-West Penn Hospital
Pittsburgh, Pennsylvania, 15224
Duke Center for Cancer Immunotherapy
Raleigh, North Carolina, 27710
About this study
Official title: C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer
The goal of this Phase 1 clinical study is test tumor infiltrating lymphocytes (known as C-TIL051) with NKTR-255 and anti-PD1 therapy for subjects with refractory non-small cell lung cancer.
The purpose of this study is to:
Read more
- Test the safety and ability for subjects to tolerate the TIL therapy
- Measure to see how the NSCLC responds to the TIL therapy
Participants will be asked to:
- Provide a tumor sample prior to the start of any treatment which will be used to make the C-TIL051.
- Receive standard of care treatment until their lung cancer no longer responds
- When necessary, the C-TIL051 will be manufactured by the sponsor and sent back to the site
- Subject will then receive chemotherapy (called lymphodepletion) for 3 days followed by 2 days of rest
- C-TIL051 will then be infused on day 0 followed by NKTR-255 (IL-15) about 12 to 24 hours later
- Pembrolizumab will be administered every 3 weeks for up to 2 years
NKTR-255 is a novel polymer-conjugated human IL-15 receptor agonist molecule designed to increase the proliferation and survival of memory CD8+ T cells and enhance the formation of long-term immunological memory which may lead to sustained anti-cancer immune response. The combination of NKTR 255 and TIL's could improve proliferation and persistence of cellular therapies leading to enhanced anti-tumor activity.
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Being tested
- C-TIL051
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-TIL051Biological
Also called Pembrolizumab, NKTR-255
C-TIL051 given in combination with IL-15 (NKTR-255) and pembrolizumab
| Study group | Role | What they receive |
|---|---|---|
| C-TIL051 | Experimental | C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab Receives: Biological: C-TIL051 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculate the Incidence of Adverse Events or Dose Limiting Toxicities
Record the incidence and severity of all adverse events or dose limiting toxicities that occur according to CTCAE criteria V5.0
Measured: up to 24 months
Secondary outcomes (4)
Calculate Objective Response Rate (ORR) of all Subjects
Measure by radiographical imaging (CT/MRI scan) the objective response rate using RECIST 1.1
Measured: up to 36 months
Calculate Duration of Response (DOR) of All Subjects
Measure by radiographical imaging (CT/MRI scan) the length of response in time.
Measured: up to 36 months
Calculate Progression Free Survival (PFS) for All Subjects
Measure by radiographical imaging (CT/MRI scan) the length of time to progression of disease.
Measured: up to 36 months
Determine Overall Survival (OS) of All Subjects
Measure by physical exam and contact reports the overall survival for all subjects following C-TIL051 treatment.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start29 Feb 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Non Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbelZeta Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676749
- Sponsor's protocol ID
- CCI-2005
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2022
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05676749
- Acronym / sponsor ID
- CCI-2005
- Conditions
- Metastatic Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision
- Enrolment
- 1 participants (actual)
- Lead sponsor
- AbelZeta Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nektar Therapeutics
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 9 Jan 2023 (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.
The goal of this Phase 1 clinical study is test tumor infiltrating lymphocytes (known as C-TIL051) with NKTR-255 and anti-PD1 therapy for subjects with refractory non-small cell lung cancer.
The purpose of this study is to:
- Test the safety and ability for subjects to tolerate the TIL therapy
- Measure to see how the NSCLC responds to the TIL therapy
Participants will be asked to:
- Provide a tumor sample prior to the start of any treatment which will be used to make the C-TIL051.
- Receive standard of care treatment until their lung cancer no longer responds
- When necessary, the C-TIL051 will be manufactured by the sponsor and sent back to the site
- Subject will then receive chemotherapy (called lymphodepletion) for 3 days followed by 2 days of rest
- C-TIL051 will then be infused on day 0 followed by NKTR-255 (IL-15) about 12 to 24 hours later
- Pembrolizumab will be administered every 3 weeks for up to 2 years
NKTR-255 is a novel polymer-conjugated human IL-15 receptor agonist molecule designed to increase the proliferation and survival of memory CD8+ T cells and enhance the formation of long-term immunological memory which may lead to sustained anti-cancer immune response. The combination of NKTR 255 and TIL's could improve proliferation and persistence of cellular therapies leading to enhanced anti-tumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-TIL051 | Experimental | Biological: C-TIL051C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to understand and give written informed consent
- Histologically and cytologically confirmed diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC) with adenocarcinoma or squamous histology
- Planned for treatment with an anti-PD1 agent
- Tumor accessible by surgery, previously not irradiated and ≥ 1.5 cm in diameter
- Measurable disease after resection of tumor by RECIST 1.1
Key exclusion criteria (20 listed)
- Previous treatment with PD1/PDL1 inhibitor for metastatic disease, Immune checkpoint blockade (ICB) given as part of definitive therapy for stage Ib-III disease with surgery or after chemo/radiation is acceptable if last dose of ICB is at least 6 months prior to enrollment in this study.
- Known driver mutations such as EGFR, ALK, ROS1, RET, METex14, and NTRK alterations.
- Current or prior use of any immunosuppressive medications within 14 days before tumor harvest
- Known active CNS metastases which are symptomatic
- History of leptomeningeal metastases
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 |
|---|---|---|
| C-TIL051Also: Pembrolizumab, NKTR-255C-TIL051 given in combination with IL-15 (NKTR-255) and pembrolizumab | Biological | C-TIL051 |
Primary outcome
Calculate the Incidence of Adverse Events or Dose Limiting Toxicities
Time frame: up to 24 months
Record the incidence and severity of all adverse events or dose limiting toxicities that occur according to CTCAE criteria V5.0
4 secondary outcomes
Calculate Objective Response Rate (ORR) of all Subjects
Time frame: up to 36 months
Calculate Duration of Response (DOR) of All Subjects
Time frame: up to 36 months
Calculate Progression Free Survival (PFS) for All Subjects
Time frame: up to 36 months
Determine Overall Survival (OS) of All Subjects
Time frame: up to 36 months
Results and safety
The study was stopped early (reason given: Sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C-TIL051 in people with Metastatic Non Small Cell Lung Cancer, run by AbelZeta Inc. at 3 sites 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 10 inclusion and 20 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: stopped early, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Sponsor decision). 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?
Calculate the Incidence of Adverse Events or Dose Limiting Toxicities (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2026.