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CAR T-cell Therapy

Treatment (STEAP1 CART, enzalutamide) for Prostate Cancer

Phase 1 & 2

Waitlist Available

Led By Jessica Hawley

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

18 years or older at the time of enrollment

Measurable disease by RECIST 1.1 criteria or bone only metastases with measurable PSA (≥ 1 ng/mL)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up anti-tumor response according to recist v1.1 or pcwg3 up to 1 year post infusion

Awards & highlights

Study Summary

This trial is testing a new treatment called STEAP1 CART, along with a medication called enzalutamide, for patients with prostate cancer that has spread to other parts of the body and is

Who is the study for?

This trial is for men with metastatic castration-resistant prostate cancer, which has spread beyond the prostate and resists treatment to lower male hormones. Participants must have tried hormone therapy and chemotherapy without success.Check my eligibility

What is being tested?

The trial tests STEAP1 CART cell therapy combined with enzalutamide, a drug blocking male hormones. It's checking if this combo can better target and kill prostate cancer cells that have spread and don't respond to usual treatments.See study design

What are the potential side effects?

Potential side effects include immune reactions from CAR T-cell infusion, such as fever or fatigue; organ inflammation; issues from hormone-blocking drugs like weakness or hot flashes; plus typical risks of biopsies and scans.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer can be measured by scans or I have cancer in the bones with a PSA level over 1.

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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 kidney function is within normal limits and I'm not on dialysis.

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My prostate cancer has worsened after treatments to lower testosterone.

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My prostate cancer has been confirmed and tested for STEAP1 at Fred Hutch/UWMC.

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My testosterone levels are below 50 ng/dL, with or without treatment.

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I am fully active or can carry out light work.

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I have taken or am ineligible for specific prostate cancer treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ anti-tumor response according to recist v1.1 or pcwg3 up to 1 year post infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~anti-tumor response according to recist v1.1 or pcwg3 up to 1 year post infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and anti-tumor response according to recist v1.1 or pcwg3 up to 1 year post 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

Duration of response (DOR)

Incidence of AEs (Phase II)

Incidence of grade 3 or higher adverse events (AEs) (Phase I)

+3 more

Secondary outcome measures

Frequency of participants that achieve a clinical benefit rate (ORR + SD) stable disease RECIST v.1.1 or PCWG3

Frequency of participants that achieve a stable disease (SD) according to RECIST v.1.1 or PCWG3

Frequency of participants that achieve an overall response rate (ORR, including complete and partial response) according to RECIST v.1.1 or PCWG3

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (STEAP1 CART, enzalutamide)Experimental Treatment13 Interventions

Patients undergo leukapheresis then receive cyclophosphamide IV and fludarabine IV on days -5, -4 and -3 and STEAP1 CART IV on day 0. Patients may receive enzalutamide PO on day 0 then QD in the absence of disease progression or unacceptable toxicity. Patients also undergo a tumor biopsy at baseline, day 14 and optionally at progression. Patients additionally undergo blood sample collection, NM bone scan and CT scan, or MRI or PET scan throughout study. Additionally, patients may undergo ECHO or MUGA at screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enzalutamide

2014

Completed Phase 4

~2760

Biopsy

2014

Completed Phase 4

~850

Echocardiography

2013

Completed Phase 4

~11670

Cyclophosphamide

1995

Completed Phase 3

~3780

Biospecimen Collection

2004

Completed Phase 2

~1730

Fludarabine

2012

Completed Phase 3

~1100

Computed Tomography

2017

Completed Phase 2

~2720

Leukapheresis

2016

Completed Phase 2

~690

Magnetic Resonance Imaging

2017

Completed Phase 3

~1190

Positron Emission Tomography

2008

Completed Phase 2

~2240

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

PromiCell Therapeutics, Inc.UNKNOWN

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,220 Total Patients Enrolled

11 Trials studying Prostate Cancer

9,613 Patients Enrolled for Prostate Cancer

Jessica HawleyPrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium

1 Previous Clinical Trials

34 Total Patients Enrolled

Frequently Asked Questions

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

Are new participants currently being actively enrolled in this clinical trial?

"According to the information available on clinicaltrials.gov, this particular trial is not actively seeking participants. The study was initially posted on May 1st, 2024 and was last updated on January 29th, 2024. However, it's worth noting that there are currently 1239 other ongoing clinical trials actively recruiting individuals at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer

2024. "Cell Therapy (STEAP1 CART) With Enzalutamide for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06236139.