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C-TIL051 in Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05676749
Recruitment Status : Recruiting
First Posted : January 9, 2023
Last Update Posted : March 1, 2024
Sponsor:
Collaborator:
Nektar Therapeutics
Information provided by (Responsible Party):
AbelZeta, Inc.

Study Description
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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:

  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.


Condition or disease Intervention/treatment Phase
Metastatic Non Small Cell Lung Cancer Biological: C-TIL051 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer
Actual Study Start Date : February 29, 2024
Estimated Primary Completion Date : March 2026
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: C-TIL051
C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab
 Biological: C-TIL051
C-TIL051 given in combination with IL-15 (NKTR-255) and pembrolizumab
Other Names:
  • Pembrolizumab
  • NKTR-255


Outcome Measures
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Primary Outcome Measures :
  1. Calculate the Incidence of Adverse Events or Dose Limiting Toxicities [ Time Frame: up to 24 months ]
    Record the incidence and severity of all adverse events or dose limiting toxicities that occur according to CTCAE criteria V5.0


Secondary Outcome Measures :
  1. Calculate Objective Response Rate (ORR) of all Subjects [ Time Frame: up to 36 months ]
    Measure by radiographical imaging (CT/MRI scan) the objective response rate using RECIST 1.1

  2. Calculate Duration of Response (DOR) of All Subjects [ Time Frame: up to 36 months ]
    Measure by radiographical imaging (CT/MRI scan) the length of response in time.

  3. Calculate Progression Free Survival (PFS) for All Subjects [ Time Frame: up to 36 months ]
    Measure by radiographical imaging (CT/MRI scan) the length of time to progression of disease.

  4. Determine Overall Survival (OS) of All Subjects [ Time Frame: up to 36 months ]
    Measure by physical exam and contact reports the overall survival for all subjects following C-TIL051 treatment.


Other Outcome Measures:
  1. Collect Blood Samples to Measure the T-cells Before and After C-TIL051 Therapy [ Time Frame: up to 24 months ]
    Collect blood samples to review information about the t-cells present prior to lymphodepleting chemotherapy and after C-TIL051 therapy.

  2. Collect Blood Samples to Measure Cytokines prior to and after C-TIL051 Therapy. [ Time Frame: up to 24 months ]
    Collect blood samples and analyze for presence of cytokines at specified intervals before and after treatment with C-TIL051.

  3. Collect Blood and Tumor Samples to Measure Circulating DNA [ Time Frame: up to 24 months ]
    Collect blood and tumor samples and analyze for circulating DNA.

  4. Collect Blood Samples to Measure Blood RNA [ Time Frame: up to 24 months ]
    Collect blood samples and analyze for RNA sequencing

  5. Perform Radiographic Imaging to Review Antitumor Activity Following Treatment [ Time Frame: up to 24 months ]
    Measure by radiographical imaging (CT/MRI scan) and assess response by immune-related response criteria (irRC).

  6. Collect and Analyze Tumor Samples for MicroOrganoSphereTM (MOS) Technology [ Time Frame: up to 36 months ]
    Collect tumor sample and review outcome measures by MicroOrganoSphereTM (MOS) Technology.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05676749


Contacts
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Contact: Christine Cornwell 240-552-5870 christine.cornwell@abelzeta.com
Contact: Shari Pearson shari.pearson@abelzeta.com

Locations
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United States, North Carolina
Duke Cancer Institute Recruiting
Raleigh, North Carolina, United States, 27710
Contact: Duke Center for Cancer Immunotherapy    919-681-6468    cci-trialreferrals@duke.edu   
Principal Investigator: Jeffrey Clarke, MD         
Sponsors and Collaborators
AbelZeta, Inc.
Nektar Therapeutics
More Information
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Responsible Party: AbelZeta, Inc.
ClinicalTrials.gov Identifier: NCT05676749    
Other Study ID Numbers: CCI-2005
First Posted: January 9, 2023    Key Record Dates
Last Update Posted: March 1, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action