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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

Clinical performance status of Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and an estimated life expectancy of ≥ 6 months

Measurable disease per RECIST v1.1 with at least one lesion identified as resectable for cell therapy manufacturing and at least one other lesion meeting the RECIST criteria for measurable disease

Must not have

History of Grade ≥ 2 pneumonitis or active interstitial lung disease/pneumonitis requiring treatment with systemic steroids

Concurrent opportunistic infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3.5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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 have at least one tumor that can be surgically removed and another that can be measured.

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had serious lung inflammation or currently have lung disease needing steroids.

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I am currently dealing with an opportunistic infection.

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I do not have any active infections, bleeding disorders, or serious illnesses.

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I have had another type of cancer in the last 3 years.

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My cancer has a mutation that responds to specific approved treatments.

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I have a history of heart problems.

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I haven't had cell therapy or an organ transplant in the last 20 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3.5 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Safety and Initial Efficacy

Phase II: Objective Response Rate (ORR)

Secondary study objectives

Clinical Benefit Rate

Duration of Response (DoR)

Overall Survival (OS)

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Fludarabine

2012

Completed Phase 4

~1860

Pembrolizumab

2017

Completed Phase 3

~3150