Engineered T Cell Therapy for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen bySusan F. Slovin, MD, Ph.D

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a phase I study which will test the safety of different doses of the patients own immune cells which have been changed to help recognize and destroy the cancer cells. The investigators want to find out what effects, good and/or bad, it has on the body and on the prostate cancer. The immune cells (T cells) used in this study will be the patients own immune cells. They will be removed from the patients blood, changed in the laboratory, and then put back into their body. T cells help the body fight infections. These cells may also kill cancer cells in some cases. Right now the patients T cells are unable to kill the cancer cells. For this reason, the physician will change the T cells by putting in a gene so that they may be able to better recognize and kill the prostate cancer cells. A gene is a portion of information which comes from the DNA and tells the cell what to do. This gene will be put into the patients T cells by a weakened virus. It is hoped that this approach will help the T cells recognize the prostate cancer tumor cells and possibly kill them. The investigators have found that T cells modified in this way were able to cure a cancer similar to Chronic Lymphocytic Leukemia in mice. However, this is an entirely new treatment for prostate cancer and it is not known if it will have any beneficial or unexpected harmful effects.

Eligibility Criteria

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.

Inclusion Criteria

I am a man and older than 18.

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

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

+7 more

Exclusion Criteria

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

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

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

+10 more

Participant Groups

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.

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.