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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.

Tracking Information
First Submitted Date  ICMJE December 7, 2022
First Posted Date  ICMJE January 9, 2023
Last Update Posted Date March 1, 2024
Actual Study Start Date  ICMJE February 29, 2024
Estimated Primary Completion Date March 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 6, 2023)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 6, 2023)
  • 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
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 6, 2023)
  • 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.
  • 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.
  • 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.
  • Collect Blood Samples to Measure Blood RNA [ Time Frame: up to 24 months ]
    Collect blood samples and analyze for RNA sequencing
  • 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).
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE C-TIL051 in Non-Small Cell Lung Cancer
Official Title  ICMJE C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Non Small Cell Lung Cancer
Intervention  ICMJE Biological: C-TIL051
C-TIL051 given in combination with IL-15 (NKTR-255) and pembrolizumab
Other Names:
  • Pembrolizumab
  • NKTR-255
Study Arms  ICMJE Experimental: C-TIL051
C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab
Intervention: Biological: C-TIL051
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 6, 2023)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2027
Estimated Primary Completion Date March 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christine Cornwell 240-552-5870 christine.cornwell@abelzeta.com
Contact: Shari Pearson shari.pearson@abelzeta.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05676749
Other Study ID Numbers  ICMJE CCI-2005
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party AbelZeta, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE AbelZeta, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Nektar Therapeutics
Investigators  ICMJE Not Provided
PRS Account AbelZeta, Inc.
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP