TERMINATED

C-TIL051 in Non-Small Cell Lung Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer

Quick Facts

Study Start:2024-02-29

Study Completion:2025-12-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:TERMINATED

Study ID

NCT05676749

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Locations (Sites)

Ochsner MD Anderson Cancer Center

New Orleans, Louisiana, 70121

United States

Duke Center for Cancer Immunotherapy

Raleigh, North Carolina, 27710

United States

Allegheny Health Network-West Penn Hospital

Pittsburgh, Pennsylvania, 15224

United States

Collaborators and Investigators

Sponsor: AbelZeta Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-29

Study Completion Date2025-12-30

Study Record Updates

Study Start Date2024-02-29

Study Completion Date2025-12-30

Terms related to this study

Additional Relevant MeSH Terms

Metastatic Non Small Cell Lung Cancer