Clinical trial · Interventional
C-TIL051 in Non-Small Cell Lung Cancer
C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decision
Summary
Brief summary (as posted)
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. 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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| C-TIL051 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C-TIL051
- description
- C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab
- interventionNames
- Biological: C-TIL051
Primary outcomes (1)
- measure
- Calculate the Incidence of Adverse Events or Dose Limiting Toxicities
- timeFrame
- up to 24 months
- description
- Record the incidence and severity of all adverse events or dose limiting toxicities that occur according to CTCAE criteria V5.0
Secondary outcomes (4)
- measure
- Calculate Objective Response Rate (ORR) of all Subjects
- timeFrame
- up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available