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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%

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting toxicity rates

Incidence of adverse events

Maximum tolerated dose of FH-A11KRASG12V-TCR

+1 more

Secondary outcome measures

Changes in tumor microenvironment

Clinical benefit rate (CBR)

ORR

+5 more

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, -4, and -3 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 throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leukapheresis

2016

Completed Phase 2

~690

Echocardiography

2013

Completed Phase 4

~11670

Bendamustine

2015

Completed Phase 3

~2950

Fludarabine

2012

Completed Phase 3

~1100

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

Biospecimen Collection

2004

Completed Phase 2

~1700

Biopsy

2014

Completed Phase 4

~1090

Computed Tomography

2017

Completed Phase 2

~2720

Cyclophosphamide

1995

Completed Phase 3

~3770

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Affini-T Therapeutics, Inc.Industry Sponsor

2 Previous Clinical Trials

107 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

557 Previous Clinical Trials

1,343,491 Total Patients Enrolled

Elena ChioreanPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

Frequently Asked Questions

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

What safety profiles have been observed for Treatment (FHA11KRASG12V-TCR) in humans?

"Due to the lack of empirical evidence concerning Treatment (FHA11KRASG12V-TCR)'s safety and efficacy, it was assigned a score of 1 on our risk assessment scale."

Answered by AI

Is enrolment in this experiment still available to participants?

"Per the data on clinicaltrials.gov, this specific trial is not actively recruiting patients at present; it was initially posted in January of 2024 and last amended in September 2023. However, there are currently 2728 other medical studies with open enrolment opportunities."

Answered by AI

What is the prime objective of this clinical trial?

"As per the trial sponsor, Affini-T Therapeutics, Inc., the main objective of this research is to measure dose-limiting toxicity rates over a one year period. Additionally, secondary outcomes like overall response rate (ORR), stable disease (SD) and clinical benefit rate (CBR) will be assessed using Response Evaluation Criteria in Solid Tumors 1.1 criteria."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Pancreatic, Colorectal and Non-Small Cell Lung Cancers With KRAS G12V Mutations

2023. "Autologous CD8+ and CD4+ Transgenic T Cells Expressing High Affinity KRASG12V Mutation-Specific T Cell Receptors (FH-A11KRASG12V-TCR) in Treating Patients With Metastatic Pancreatic, Colorectal and Non-Small Cell Lung Cancers With KRAS G12V Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06043713.