ClinicalTrials.Veeva

Menu

C-TIL051 in Non-Small Cell Lung Cancer

A

AbelZeta

Status and phase

Enrolling
Phase 1

Conditions

Metastatic Non Small Cell Lung Cancer

Treatments

Biological: C-TIL051

Study type

Interventional

Funder types

Industry

Identifiers

NCT05676749
CCI-2005

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

C-TIL051
Experimental group
Description:
C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab
Treatment:
Biological: C-TIL051

Trial contacts and locations

1

Loading...

Central trial contact

Shari Pearson; Christine Cornwell

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems