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CAR T-cell Therapy

Engineered T-Cell Therapy for Lung Cancer

Phase 1

Recruiting

Led By Elena Chiorean

Research Sponsored by Fred Hutchinson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Previously documented KRASG12V mutation in tumor or plasma cell-free deoxyribonucleic acid (cfDNA) specimens by PCR or NGS test

Cardiac: Participants 60 years of age or older must have LVEF evaluation performed within 60 days prior to enrollment and LVEF must be >= 35%

Must not have

Prior solid organ transplant or allogeneic hematopoietic stem cell transplant

Active autoimmune disease requiring immunosuppressive therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the time of lymphodepletion chemotherapy to 28 days after fh-a11krasg12v-tcr infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial tests new T cells that can recognize and kill tumor cells in patients with pancreatic, colorectal, and non-small cell lung cancer. T cells will come from the patient and a new gene will be added to make them target tumor cells.

Who is the study for?

This trial is for adults with metastatic pancreatic, colorectal, or non-small cell lung cancers that have a specific KRAS G12V mutation. Participants must have tried or declined standard treatments and be in good overall health with proper organ function. They should not be pregnant, breastfeeding, planning to conceive soon, or have uncontrolled illnesses. A commitment to use effective contraception during the study and for 4 months after is required.

What is being tested?

The trial tests genetically modified T cells designed to target cancer cells with the KRAS G12V mutation. Patients' own T cells are extracted and engineered to recognize this mutation before being reintroduced into their bodies. The goal is to see if these modified T cells can effectively attack the cancer cells in patients with advanced stages of certain cancers.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as fever, fatigue, and flu-like symptoms; possible damage to normal tissues; infusion-related reactions; increased risk of infections due to immune system modification; and other unforeseen complications from genetic engineering of T-cells.

Eligibility Criteria

Inclusion Criteria

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

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My cancer has a KRASG12V mutation.

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I am 60 or older and my heart's pumping ability is at least 35%.

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My kidneys work well enough (creatinine clearance >= 50 ml/min).

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My total bilirubin level is less than 2.0 mg/dL.

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I have been diagnosed with metastatic pancreatic, colorectal, or non-small cell lung cancer.

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My cancer type has been confirmed by a specific pathology review.

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I am 18 years old or older.

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I have mild or no shortness of breath and my oxygen levels are above 92% without extra oxygen.

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My genetic test shows I have the HLA-A*11:01 gene.

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My cancer has worsened or I can't tolerate or have refused standard treatment.

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I don't need frequent drainage for fluid buildup in my chest or abdomen.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have had a solid organ or bone marrow transplant.

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I am on medication for an autoimmune disease.

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I have brain metastases that have not been treated.

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I currently have an infection that is not under control.

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I need frequent drainage for fluid build-up in my chest or abdomen.

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I am taking a high dose of steroids, more than 0.5 mg/kg of prednisone daily.

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I am currently being treated for side effects from previous immunotherapy.

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I do not have any severe illnesses like heart failure or mental health issues that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the time of lymphodepletion chemotherapy to 28 days after fh-a11krasg12v-tcr infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the time of lymphodepletion chemotherapy to 28 days after fh-a11krasg12v-tcr infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the time of lymphodepletion chemotherapy to 28 days after fh-a11krasg12v-tcr infusion for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Dose-limiting toxicity rates

Incidence of adverse events

Maximum tolerated dose of FH-A11KRASG12V-TCR

+1 more

Secondary study objectives

Changes in tumor microenvironment

Clinical benefit rate (CBR)

ORR

+5 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: Treatment (FHA11KRASG12V-TCR)Experimental Treatment12 Interventions

Patients undergo leukapheresis prior to treatment and receive lymphodepletion chemotherapy with either cyclophosphamide IV and fludarabine IV on days -6, -5, and -4, or bendamustine IV on days -4 and -3 at the discretion of the treating clinician and/or PI. Patients then receive FHA11KRASG12V-TCR IV on day 0. Patients may receive an additional FHA11KRASG12V-TCR IV infusion as soon as 28 days or up to 1 year after the first infusion. Patients undergo ECHO or MUGA during screening. Patients also undergo CT, PET or MRI as well as blood sample collection and a tissue biopsy at baseline and throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 4

~1830

Multigated Acquisition Scan

2015

Completed Phase 3

~270