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Gene Editing Therapy

Genetically-Engineered Immune Cells for Lung Cancer (CheckCell-2 Trial)

Phase 1 & 2
Waitlist Available
Led By Emil Lou, MD, PhD
Research Sponsored by Intima Bioscience, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Agrees to remain near the treatment site after the investigational product infusion through the Day 28/Week 4 follow-up visit
Confirmed histologic diagnosis of either PD-L1 negative or positive metastatic non-small cell lung cancer (NSCLC)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3.5 years
Awards & highlights

CheckCell-2 Trial Summary

This trial is testing a new way to treat lung cancer using genetically-engineered immune cells. The goal is to see if this new treatment is safe and effective.

Who is the study for?
Adults aged 18-70 with metastatic non-small cell lung cancer (NSCLC), either PD-L1 negative or positive, who are candidates for first-line anti-PD-1/anti-PD-L1 immunotherapy with chemo. They must have good organ function, agree to use contraception, and can stay near the treatment site for follow-ups. Exclusions include those with certain medical conditions, prior malignancies within 3 years, severe allergies to specific drugs, recent live vaccines, active infections or coagulation disorders.Check my eligibility
What is being tested?
The trial is testing genetically-engineered Tumor Infiltrating Lymphocytes (TIL) where CISH has been inactivated using CRISPR gene editing. This is combined with standard treatments like Pembrolizumab and chemotherapy to see if it's safe and effective against metastatic NSCLC.See study design
What are the potential side effects?
Potential side effects may include immune reactions due to genetic engineering of T cells, infusion-related responses from TIL therapy or Pembrolizumab administration; effects from high-dose aldesleukin such as low blood pressure; plus typical chemotherapy side effects like nausea and hair loss.

CheckCell-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I agree to stay near the treatment site until the 4-week follow-up.
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My lung cancer is confirmed as non-small cell type, with any PD-L1 status.
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I agree to use effective birth control.
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I am mostly active and my doctors believe I have 6 or more months to live.
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I am eligible for or started anti-PD-1/PD-L1 and chemotherapy within the last 6 months (Phase 1) or 3 months (Phase 2).
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I have at least one tumor that can be surgically removed and another that can be measured.
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My organs are functioning well enough for me to join the study.
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I am between 18 and 70 years old.
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My lung cancer is confirmed as non-small cell type, with any PD-L1 status.

CheckCell-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3.5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3.5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Safety and Initial Efficacy
Phase II: Objective Response Rate (ORR)
Secondary outcome measures
Clinical Benefit Rate
Duration of Response (DoR)
Overall Survival (OS)
+3 more

CheckCell-2 Trial Design

4Treatment groups
Experimental Treatment
Group I: CISH CRISPR TIL plus pembrolizumab / Phase I ArmExperimental Treatment5 Interventions
Dose Expansion with Maintenance Therapy Cohort Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +escalating doses of CISH inactivated TIL + high-dose aldesleukin Maintenance pembrolizumab during follow-up
Group II: CISH CRISPR TIL / Phase II Arm PD-L1 Positive CohortExperimental Treatment5 Interventions
PD-L1 positive is defined as tumors with a PD-L1 Tumor Proportion Score (TPS) ≥ 1%. Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +recommended phase II dose (from phase I) of CISH inactivated TIL + high-dose aldesleukin May include maintenance pembrolizumab during follow-up
Group III: CISH CRISPR TIL / Phase II Arm PD-L1 Negative CohortExperimental Treatment5 Interventions
Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +recommended phase II dose (from phase I) of CISH inactivated TIL + high-dose aldesleukin May include maintenance pembrolizumab during follow-up
Group IV: CISH CRISPR TIL / Phase I ArmExperimental Treatment4 Interventions
Dose Escalation/Expansion Cohort Non-myeloablative, lymphodepleting preparative regimen of cyclophosphamide and fludarabine +escalating doses of CISH inactivated TIL + high-dose aldesleukin
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Aldesleukin
2012
Completed Phase 4
~1620
Pembrolizumab
2017
Completed Phase 2
~1950
Fludarabine
2012
Completed Phase 3
~1090

Find a Location

Who is running the clinical trial?

Intima Bioscience, Inc.Lead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Emil Lou, MD, PhDPrincipal InvestigatorDivision of Hematology, Oncology, and Transplantation, University of Minnesota
1 Previous Clinical Trials
20 Total Patients Enrolled
Erminia Massarelli, MD, PhD, MSPrincipal InvestigatorDepartment of Medical Oncology & Therapeutics Research, City of Hope

Media Library

CISH Inactivated TIL (Gene Editing Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05566223 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: CISH CRISPR TIL / Phase II Arm PD-L1 Negative Cohort, CISH CRISPR TIL / Phase II Arm PD-L1 Positive Cohort, CISH CRISPR TIL / Phase I Arm, CISH CRISPR TIL plus pembrolizumab / Phase I Arm
Non-Small Cell Lung Cancer Clinical Trial 2023: CISH Inactivated TIL Highlights & Side Effects. Trial Name: NCT05566223 — Phase 1 & 2
CISH Inactivated TIL (Gene Editing Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05566223 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does your research include individuals aged 55 or older?

"This research project is open to individuals aged 18 and over, up until the age of 75."

Answered by AI

What criteria must one meet to partake in this clinical examination?

"This clinical trial is recruiting 70 individuals diagnosed with squamous cell carcinoma between the ages of 18 and 75. Applicants must meet a number of criteria, such as having confirmed histologic diagnosis for metastatic NSCLC (PD-L1 negative or positive) that can be treated with anti-PD-1/anti-PD-L1 immunotherapy plus chemotherapy, measurable disease per RECIST version 1.1., ECOG performance status 0 or 1, and more. Patients who have already started first line treatment are also eligible under certain conditions outlined in the requirements list."

Answered by AI

Are new participants welcome to join this research endeavor?

"Data hosted on clinicaltrials.gov reveals that, as of September 30th 2022, this particular research trial has ceased its recruitment activities; it was initially posted to the website in November 1st 2022. Fortunately, there are 1946 other medical studies actively enrolling patients at the moment."

Answered by AI

What are the key aims of this investigation?

"Intima Bioscience, Inc., the study sponsor has set a 3.5 year timeline to evaluate Phase 1 Safety and Initial Efficacy as their primary objective. Toxicity incidence, overall survival (Kaplan-Meier estimate), and duration of response are all secondary outcomes that will be measured by researchers during this period."

Answered by AI
~40 spots leftby Nov 2025