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CAR T-cell Therapy

Engineered T Cell Therapy for Prostate Cancer

Phase 1

Waitlist Available

Led By Susan Slovin, MD, PhD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Karnofsky Performance Scale (KPS) greater or equal to 70%

Evidence of metastatic disease in bone on imaging

Must not have

History of non-prostate, primary, malignant cancer within previous five years, except non-melanoma skin cancer

Recent radiation therapy, more than one prior chemotherapy, or specific medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether adding a gene to patients' T cells can help them better recognize and kill prostate cancer cells.

Who is the study for?

This trial is for men over 18 with advanced prostate cancer that has spread and is resistant to hormone therapy. They must have a good performance status, adequate organ function, no HIV or hepatitis, and agree to use contraception. Excluded are those with other cancers within five years (except non-melanoma skin cancer), severe heart or lung disease, recent radiation therapy, immunosuppressive treatments, certain medications for prostate cancer, active CNS metastases, infections requiring antibiotics shortly before the trial starts.

What is being tested?

The study tests different doses of modified T cells from the patient's own body designed to target and kill prostate cancer cells. It's a phase I safety trial aiming to see how these engineered immune cells affect both the body and the progression of prostate cancer.

What are the potential side effects?

Potential side effects may include reactions related to immune response such as fever or fatigue; complications from cell transfer like infection risk; possible damage to healthy tissues by targeted T cells; allergic reactions due to viral vectors used in gene modification.

Eligibility Criteria

Inclusion Criteria

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

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I am mostly able to care for myself but may not be able to do active work.

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My cancer has spread to my bones, confirmed by scans.

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My testosterone levels are very low due to hormone therapy.

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My prostate cancer was confirmed by a test at MSKCC.

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My prostate cancer is worsening despite low testosterone levels.

Exclusion Criteria

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

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I have not had any cancer other than non-melanoma skin cancer in the last 5 years.

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I have had radiation, more than one chemotherapy, or certain medications recently.

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My cancer has spread to my brain or spinal cord and is causing symptoms.

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I have had my spleen removed.

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I have an autoimmune or antibody-mediated disease.

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I need daily corticosteroids or immunosuppressants.

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I have serious heart or severe lung problems.

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I am allergic to ganciclovir or acyclovir.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The safety and tolerability of immunotherapy

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: autologous T cells & cyclophosphamide.Experimental Treatment2 Interventions

This is a phase I dose escalation study to assess the safety and tolerability using increasing doses of engineered autologous T cells targeted to Prostate-Specific Membrane Antigen (PSMA) administered one day after pretreatment with cyclophosphamide.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cyclophosphamide

1994

Completed Phase 3

~8140

0 / 13Eligibility criteria met