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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
Must not have
Hypersensitivity to anti-PD1 agent, cyclophosphamide, fludarabine, interleukin-2, gentamicin, or any excipient
Women of childbearing potential or fertile men who are unwilling to use effective contraception during study and 6 months after treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am allergic to certain cancer drugs or their ingredients.
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I am willing to use contraception during and 6 months after the study.
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I have a history of HIV/AIDS, hepatitis C, hepatitis B, or another serious chronic infection.
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I have brain metastases causing symptoms.
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I have had cancer spread to the lining of my brain and spinal cord.
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I do not have any unmanaged ongoing illnesses.
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I have been treated with PD1/PDL1 inhibitors for my metastatic disease.
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I need more than 2 liters of oxygen due to my lung condition.
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I have received an organ from another person.
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I have not needed IV antibiotics for an infection within the last week.
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I am on strong medication for an autoimmune disease, not just low-dose prednisone.
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My cancer has specific genetic changes like EGFR or ALK.
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I am not pregnant or breastfeeding.
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I have no major side effects from past treatments.
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I have had lung inflammation due to an autoimmune disease that needed treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Calculate the Incidence of Adverse Events or Dose Limiting Toxicities
Secondary study objectives
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 more
Other study objectives
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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
10,296 Total Patients Enrolled
AbelZeta, Inc.Lead Sponsor
Cellular Biomedicine Group, Inc.Lead Sponsor
2 Previous Clinical Trials
124 Total Patients Enrolled

Media Library

C-TIL051 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05676749 — Phase 1
Lung Cancer Research Study Groups: C-TIL051
Lung Cancer Clinical Trial 2023: C-TIL051 Highlights & Side Effects. Trial Name: NCT05676749 — Phase 1
C-TIL051 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05676749 — Phase 1
~12 spots leftby Mar 2026
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