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CAR T-cell Therapy
C-TIL051 + Anti-PD1 Therapy for Lung Cancer
Phase 1
Recruiting
Research Sponsored by AbelZeta, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Histologically and cytologically confirmed diagnosis of stage IV or recurrent non-small cell lung cancer (NSCLC) with adenocarcinoma or squamous histology
Tumor accessible by surgery, previously not irradiated and ≥ 1.5 cm in diameter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
Study Summary
This trial tests C-TIL051 with anti-PD1 therapy for people with refractory non-small cell lung cancer. It assesses safety & ability to tolerate treatment, & response of the cancer. Participants provide a tumor sample & receive chemo & C-TIL051 & anti-PD1.
Who is the study for?
This trial is for adults with stage IV or recurrent non-small cell lung cancer (NSCLC) who haven't responded to standard treatments. They must have a heart function test showing normal results, adequate organ and marrow function, and no serious infections like HIV or hepatitis. Pregnant women, those unwilling to use contraception, and patients with certain lung conditions or recent immunosuppressive drug use are excluded.Check my eligibility
What is being tested?
The study tests C-TIL051 combined with NKTR-255 and anti-PD1 therapy in NSCLC patients whose cancer hasn't improved with standard care. It involves taking a tumor sample to create C-TIL051, chemotherapy preparation, followed by infusions of C-TIL051 and NKTR-255, then regular Pembrolizumab injections for up to two years.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's increased activity such as inflammation in various organs, infusion-related reactions from the treatment administration process itself, fatigue due to body's response to therapy components like chemotherapy agents used during lymphodepletion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer is confirmed to be stage IV or recurrent NSCLC with adenocarcinoma or squamous cell type.
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My tumor can be removed by surgery, hasn't been treated with radiation, and is at least 1.5 cm big.
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My cancer can be measured by scans after surgery.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am scheduled for treatment with an anti-PD1 medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Calculate the Incidence of Adverse Events or Dose Limiting Toxicities
Secondary outcome measures
Calculate Duration of Response (DOR) of All Subjects
Calculate Objective Response Rate (ORR) of all Subjects
Calculate Progression Free Survival (PFS) for All Subjects
+1 moreOther outcome measures
Collect Blood Samples to Measure Blood RNA
Collect Blood Samples to Measure Cytokines prior to and after C-TIL051 Therapy.
Collect Blood Samples to Measure the T-cells Before and After C-TIL051 Therapy
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: C-TIL051Experimental Treatment1 Intervention
C-TIL051 plus IL-15 (NKTR-255) and Pembrolizumab
Find a Location
Who is running the clinical trial?
Nektar TherapeuticsIndustry Sponsor
58 Previous Clinical Trials
10,322 Total Patients Enrolled
AbelZeta, Inc.Lead Sponsor
Cellular Biomedicine Group, Inc.Lead Sponsor
2 Previous Clinical Trials
196 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to certain cancer drugs or their ingredients.I am willing to use contraception during and 6 months after the study.I have not received a live vaccine within the last 30 days.I have a history of HIV/AIDS, hepatitis C, hepatitis B, or another serious chronic infection.Your recent lung function tests show that your lungs are working well.My lung cancer is confirmed to be stage IV or recurrent NSCLC with adenocarcinoma or squamous cell type.Your heart tests from the past 6 months show that your heart is working well and there are no signs of heart problems.I have brain metastases causing symptoms.I have had cancer spread to the lining of my brain and spinal cord.My organs and bone marrow are working well.I do not have any unmanaged ongoing illnesses.I have been treated with PD1/PDL1 inhibitors for my metastatic disease.I need more than 2 liters of oxygen due to my lung condition.I haven't taken immunosuppressive drugs in the last 14 days.I have received an organ from another person.I have not needed IV antibiotics for an infection within the last week.You have a history of a weakened immune system from birth.I haven't had active treatment for another cancer besides skin cancer in the last 2 years.I am on strong medication for an autoimmune disease, not just low-dose prednisone.My cancer has specific genetic changes like EGFR or ALK.I am not pregnant or breastfeeding.I have no major side effects from past treatments.I have had lung inflammation due to an autoimmune disease that needed treatment.My tumor can be removed by surgery, hasn't been treated with radiation, and is at least 1.5 cm big.You are expected to live for more than 6 months.My cancer can be measured by scans after surgery.I am fully active and can carry on all my pre-disease activities without restriction.I am scheduled for treatment with an anti-PD1 medication.
Research Study Groups:
This trial has the following groups:- Group 1: C-TIL051
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What potential adverse effects are associated with C-TIL051?
"As the trial for C-TIL051 is only in its first phase, there is limited evidence of efficacy and safety; consequently, it was awarded a score of 1."
Answered by AI
Is the enrollment window currently open for this research study?
"This clinical trial is no longer actively seeking participants. Although the post was initially made on March 1st 2023 and last updated June 1st of the same year, it has since been closed to recruitment. Thankfully, 1856 other medical trials are currently enrolling patients."
Answered by AI
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