Testing a new treatment for advanced non-small cell lung cancer
C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer
This study is testing a new treatment combining special immune cells and other therapies to see if it can help people with advanced non-small cell lung cancer whose current treatments aren't working.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AbelZeta Inc. Industry-sponsored |
| Drugs / interventions | radiation, cyclophosphamide, fludarabine, prednisone, Pembrolizumab, chemotherapy |
| Locations | 4 sites (La Jolla, California and 3 other locations) |
| Trial ID | NCT05676749 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical study aims to evaluate the safety and tolerability of tumor infiltrating lymphocytes (C-TIL051) combined with NKTR-255 and anti-PD1 therapy in patients with refractory metastatic non-small cell lung cancer (NSCLC). Participants will provide a tumor sample for C-TIL051 production and will receive standard care until their cancer progresses. Following a lymphodepletion chemotherapy regimen, C-TIL051 will be infused, followed by NKTR-255 and pembrolizumab administered every three weeks for up to two years. The study will measure the response of NSCLC to this innovative treatment approach.
Who should consider this trial
Good fit: Ideal candidates include individuals with stage IV or recurrent non-small cell lung cancer who are planned for treatment with an anti-PD1 agent and meet specific health criteria.
Not a fit: Patients who have previously received PD1/PDL1 inhibitors for metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced non-small cell lung cancer who have not responded to existing therapies.
How similar studies have performed: While this approach is innovative, similar studies using tumor infiltrating lymphocytes and immunotherapy have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
La Jolla, California and 3 other locations
- UC San Diego Moores Cancer Center — La Jolla, California, United States (Recruiting)
- Ochsner MD Anderson Cancer Center — New Orleans, Louisiana, United States (Recruiting)
- Duke Center for Cancer Immunotherapy — Raleigh, North Carolina, United States (Recruiting)
- Allegheny Health Network-West Penn Hospital — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Christine Cornwell
- Email: christine.cornwell@abelzeta.com
- Phone: 240-552-5870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.