C-TIL051 in Non-Small Cell Lung Cancer

NCT05676749 | Terminated Phase 1 FDA Drug

• 1 other identifier: CCI-2005
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief 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:

• 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

Outcome Measures

Primary Outcomes (1)

• 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

  up to 24 months

Secondary Outcomes (4)

• Calculate Objective Response Rate (ORR) of all Subjects

  up to 36 months

• Calculate Duration of Response (DOR) of All Subjects

  up to 36 months

• Calculate Progression Free Survival (PFS) for All Subjects

  up to 36 months

• Determine Overall Survival (OS) of All Subjects

  up to 36 months

Other Outcomes (6)

• Collect Blood Samples to Measure the T-cells Before and After C-TIL051 Therapy

  up to 24 months

• Collect Blood Samples to Measure Cytokines prior to and after C-TIL051 Therapy.

  up to 24 months

• Collect Blood and Tumor Samples to Measure Circulating DNA

  up to 24 months

Study Arms (1)

C-TIL051

EXPERIMENTAL

C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab

Biological: C-TIL051

Interventions

C-TIL051 BIOLOGICAL

C-TIL051 given in combination with IL-15 (NKTR-255) and pembrolizumab

Also known as: Pembrolizumab, NKTR-255

C-TIL051

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbelZeta Inc.: lead
• Nektar Therapeutics: collaborator

Study Sites (3)

Ochsner MD Anderson Cancer Center

New Orleans, Louisiana, 70121, United States

Location

Duke Center for Cancer Immunotherapy

Raleigh, North Carolina, 27710, United States

Location

Allegheny Health Network-West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; NKTR-255

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: January 9, 2023
• Study Start: February 29, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)