To hear about similar clinical trials, please enter your email below
Trial Title:
C-TIL051 in Non-Small Cell Lung Cancer
NCT ID:
NCT05676749
Condition:
Metastatic Non Small Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Pembrolizumab
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
C-TIL051
Description:
C-TIL051 given in combination with IL-15 (NKTR-255) and pembrolizumab
Arm group label:
C-TIL051
Other name:
Pembrolizumab
Other name:
NKTR-255
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:
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UC San Diego Moores Cancer Center
Address:
City:
La Jolla
Zip:
92093
Country:
United States
Status:
Recruiting
Contact:
Last name:
CancerCTO UCSD Health
Phone:
858-822-+5354
Email:
cancerCTO@health.ucsd.edu
Contact backup:
Last name:
Sandip Patel, MD
Facility:
Name:
Ochsner MD Anderson Cancer Center
Address:
City:
New Orleans
Zip:
70121
Country:
United States
Status:
Recruiting
Contact:
Last name:
Duaa Hashm, MS, BSN, RN
Phone:
504-703-1340
Email:
duaa.hashm@ochsner.org
Contact backup:
Last name:
Daniel Johnson, MD
Facility:
Name:
Duke Center for Cancer Immunotherapy
Address:
City:
Raleigh
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Duke Center for Cancer Immunotherapy
Phone:
919-681-6468
Email:
cci-trialreferrals@duke.edu
Contact backup:
Last name:
Jeffrey Clarke, MD
Facility:
Name:
Allegheny Health Network-West Penn Hospital
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials AHN
Phone:
412-330-6151
Email:
clinicaltrials@ahn.org
Contact backup:
Last name:
Yazan Samhouri, MD
Start date:
February 29, 2024
Completion date:
August 2027
Lead sponsor:
Agency:
AbelZeta, Inc.
Agency class:
Industry
Collaborator:
Agency:
Nektar Therapeutics
Agency class:
Industry
Source:
AbelZeta, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05676749
