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CAR T-cell Therapy

CAR T-cell Therapy for Prostate Cancer

Phase 1
Waitlist Available
Led By Michael Schweizer
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
Evidence of L1CAM positivity by immunohistochemistry review of the patient's archival/fresh tumor samples
Measurable disease per RECIST v1.1 criteria as determined by CT, MRI or positron emission tomography (PET) scan
Must not have
History of an autoimmune disease requiring immunosuppressant therapy within the past 5 years
Known history of unstable angina or myocardial infarction (MI) within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 28 days of last car t cell infusion
Awards & highlights

Summary

This trial tests a new immune therapy to treat small cell neuroendocrine prostate cancer that has spread and can't be removed by surgery. CAR T-cells are modified to recognize and kill cancer cells.

Who is the study for?
This trial is for adults with small cell neuroendocrine prostate cancer that's advanced locally or spread elsewhere and can't be surgically removed. They must have had platinum-based chemo, no severe chronic respiratory illness, brain metastases, significant heart issues, uncontrolled infections or certain autoimmune diseases in the last 5 years. Participants need to agree to contraception use and have a life expectancy over 3 months.
What is being tested?
The trial tests autologous CAR T-cell therapy using patients' own immune cells modified to target L1CAM protein on tumor cells. It aims to determine the best dose and side effects of these engineered T-cells in treating advanced prostate cancer that expresses L1CAM.
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as fever, fatigue, inflammation in various organs; there may also be risks associated with infusion of modified cells like low blood pressure or breathing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My tumor is L1CAM positive based on a special lab test.
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My cancer can be measured by scans.
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I am 18 years old or older.
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My cancer has spread and cannot be removed with surgery.
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My kidney function, measured by creatinine, is within the normal range.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My side effects from previous cancer treatments are mild.
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I have been treated with platinum-based chemotherapy for small cell neuroendocrine prostate cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been on immunosuppressants for an autoimmune disease in the last 5 years.
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I have had a heart attack or unstable heart pain in the last 6 months, or I need treatment for an irregular heartbeat.
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I have severe heart issues, including heart failure or very low heart pump efficiency.
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My lung function is good and I don't have severe breathing problems at rest.
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I have a known history of cancer spreading to my brain.
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I haven't needed IV antibiotics for an infection in the last 2 weeks and don't have an uncontrolled infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 28 days of last car t cell infusion
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 28 days of last car t cell 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
Secondary outcome measures
Objective response
Overall survival
Radiographic progression free survival

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (autologous L1CAM-specific CAR+EGFRt+ T cells)Experimental Treatment13 Interventions
Patients undergo leukapheresis to obtain PBMCs for T cell product manufacturing and may undergo bridging therapy at the discretion of the treating clinician on study. Patients then undergo lymphodepleting chemotherapy with cyclophosphamide IV and fludarabine IV on days -5, -4 and -33 or single agent bendamustine on days -4 and -3 at the discretion of the treating clinician and/or PI. Patients receive an autologous L1CAM-specific CAR+EGFRt+ T cells infusion on day 0. Based on disease response and persistence of CAR T cells, patients may receive additional lymphodepletion chemotherapy and an autologous L1CAM-specific CAR+EGFRt+ T cell infusion as soon as 6 weeks and no later than 24 weeks after the first infusion, or at the discretion of the PI. Patients also undergo ECHO or MUGA during screening. Patients undergo x-ray imaging, CT, bone scan, and blood sample collection throughout the trial. Additionally, patients may undergo tissue biopsy on the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leukapheresis
2016
Completed Phase 2
~690
Biospecimen Collection
2004
Completed Phase 2
~1720
Cyclophosphamide
1995
Completed Phase 3
~3770
Bone Scan
2015
Completed Phase 2
~50
Echocardiography
2013
Completed Phase 4
~11670
Bendamustine
2015
Completed Phase 3
~3240
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2720
Fludarabine
2012
Completed Phase 3
~1020
Multigated Acquisition Scan
2015
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer CenterLead Sponsor
558 Previous Clinical Trials
1,345,565 Total Patients Enrolled
10 Trials studying Prostate Cancer
9,593 Patients Enrolled for Prostate Cancer
Bristol-Myers SquibbIndustry Sponsor
2,652 Previous Clinical Trials
4,130,729 Total Patients Enrolled
42 Trials studying Prostate Cancer
5,548 Patients Enrolled for Prostate Cancer
Michael SchweizerPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
10 Previous Clinical Trials
124 Total Patients Enrolled
~13 spots leftby Mar 2028
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