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C-TIL051 in Non-Small Cell Lung Cancer

Primary Purpose

Metastatic Non Small Cell Lung Cancer

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
C-TIL051
Sponsored by
Cellular Biomedicine Group, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

C-TIL051

Arm Description

C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab

Outcomes

Primary Outcome Measures

Calculate the Incidence of Adverse Events or Dose Limiting Toxicities
Record the incidence and severity of all adverse events or dose limiting toxicities that occur according to CTCAE criteria V5.0

Secondary Outcome Measures

Calculate Objective Response Rate (ORR) of all Subjects
Measure by radiographical imaging (CT/MRI scan) the objective response rate using RECIST 1.1
Calculate Duration of Response (DOR) of All Subjects
Measure by radiographical imaging (CT/MRI scan) the length of response in time.
Calculate Progression Free Survival (PFS) for All Subjects
Measure by radiographical imaging (CT/MRI scan) the length of time to progression of disease.
Determine Overall Survival (OS) of All Subjects
Measure by physical exam and contact reports the overall survival for all subjects following C-TIL051 treatment.

Full Information

First Posted
December 7, 2022
Last Updated
September 13, 2023
Sponsor
Cellular Biomedicine Group, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05676749
Brief Title
C-TIL051 in Non-Small Cell Lung Cancer
Official Title
C-TIL051 in Anti-PD1 Resistant Metastatic Non-Small Cell Lung Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
March 2026 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellular Biomedicine Group, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this Phase 1 clinical study is test tumor infiltrating lymphocytes (known as C-TIL051) with anti-PD1 therapy for subjects with refractory non-small cell lung cancer. The purpose of this study is to: Test the safety and ability for subjects to tolerate the TIL therapy 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 IL-15 about 12 to 24 hours later Pembrolizumab will be administered every 3 weeks for up to 2 years

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C-TIL051
Arm Type
Experimental
Arm Description
C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab
Intervention Type
Biological
Intervention Name(s)
C-TIL051
Other Intervention Name(s)
Pembrolizumab, NKTR-255
Intervention Description
C-TIL051 given in combination with IL-15 (NKTR-255) and pembrolizumab
Primary Outcome Measure Information:
Title
Calculate the Incidence of Adverse Events or Dose Limiting Toxicities
Description
Record the incidence and severity of all adverse events or dose limiting toxicities that occur according to CTCAE criteria V5.0
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
Calculate Objective Response Rate (ORR) of all Subjects
Description
Measure by radiographical imaging (CT/MRI scan) the objective response rate using RECIST 1.1
Time Frame
up to 36 months
Title
Calculate Duration of Response (DOR) of All Subjects
Description
Measure by radiographical imaging (CT/MRI scan) the length of response in time.
Time Frame
up to 36 months
Title
Calculate Progression Free Survival (PFS) for All Subjects
Description
Measure by radiographical imaging (CT/MRI scan) the length of time to progression of disease.
Time Frame
up to 36 months
Title
Determine Overall Survival (OS) of All Subjects
Description
Measure by physical exam and contact reports the overall survival for all subjects following C-TIL051 treatment.
Time Frame
up to 36 months
Other Pre-specified Outcome Measures:
Title
Collect Blood Samples to Measure the T-cells Before and After C-TIL051 Therapy
Description
Collect blood samples to review information about the t-cells present prior to lymphodepleting chemotherapy and after C-TIL051 therapy.
Time Frame
up to 24 months
Title
Collect Blood Samples to Measure Cytokines prior to and after C-TIL051 Therapy.
Description
Collect blood samples and analyze for presence of cytokines at specified intervals before and after treatment with C-TIL051.
Time Frame
up to 24 months
Title
Collect Blood and Tumor Samples to Measure Circulating DNA
Description
Collect blood and tumor samples and analyze for circulating DNA.
Time Frame
up to 24 months
Title
Collect Blood Samples to Measure Blood RNA
Description
Collect blood samples and analyze for RNA sequencing
Time Frame
up to 24 months
Title
Perform Radiographic Imaging to Review Antitumor Activity Following Treatment
Description
Measure by radiographical imaging (CT/MRI scan) and assess response by immune-related response criteria (irRC).
Time Frame
up to 24 months
Title
Collect and Analyze Tumor Samples for MicroOrganoSphereTM (MOS) Technology
Description
Collect tumor sample and review outcome measures by MicroOrganoSphereTM (MOS) Technology.
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Cornwell
Phone
240-552-5870
Email
christine.cornwell@cellbiomedgroup.com
Facility Information:
Facility Name
Duke Cancer Institute
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christy Arrowood, RN, BSN, MSHS
Phone
919-613-6130
Email
christy.arrowood@duke.edu
First Name & Middle Initial & Last Name & Degree
Jeffrey Clarke, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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C-TIL051 in Non-Small Cell Lung Cancer

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