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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The safety and tolerability of immunotherapy
Secondary outcome measures
Changes in biomarkers of bone metastasis and metabolism
Changes in bone metastases
Changes in circulating tumor cells
+3 moreTrial 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
Find a Location
Who is running the clinical trial?
United States Department of DefenseFED
861 Previous Clinical Trials
227,181 Total Patients Enrolled
38 Trials studying Prostate Cancer
9,191 Patients Enrolled for Prostate Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,607 Total Patients Enrolled
132 Trials studying Prostate Cancer
52,061 Patients Enrolled for Prostate Cancer
Susan Slovin, MD, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
256 Total Patients Enrolled
7 Trials studying Prostate Cancer
211 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.My testosterone levels are very low due to hormone therapy.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.I have had my spleen removed.I have an autoimmune or antibody-mediated disease.I recently needed antibiotics for an infection.I need daily corticosteroids or immunosuppressants.I have received all required vaccines within the specified timeframes.My prostate cancer was confirmed by a test at MSKCC.My prostate cancer is worsening despite low testosterone levels.I have serious heart or severe lung problems.I am allergic to ganciclovir or acyclovir.
Research Study Groups:
This trial has the following groups:- Group 1: autologous T cells & cyclophosphamide.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants can the clinical trial accommodate?
"Presently, this trial is not enrolling new patients. Initially posted on June 1st 2010 and updated as recently as November 28th 2022, there are currently 1321 clinical trials for prostate cancer and 816 for engineered autologous T cells actively recruiting participants if you are seeking alternative studies."
Answered by AI
To what degree might patients be exposed to peril when using engineered autologous T cells?
"The safety rating for engineered autologous T cells is 1 due to the limited clinical data collected during Phase 1 studies, which assess basic efficacy and scant amounts of safety information."
Answered by AI
For what condition is autologous T cell engineering commonly employed?
"Autologous T cells, which have been modified for therapeutic use, can be employed to manage multiple sclerosis and a variety of other oncological conditions such as mixed-cell type lymphoma, acute myelocytic leukemia, and retinoblastoma."
Answered by AI
Has research been conducted regarding the efficacy of genetically altered autologous T cells?
"816 medical trials focusing on engineered autologous T cells are underway, with 154 already in Phase 3. While much of the research is concentrated around Philadelphia, Pennsylvania, 27824 different locations across the world have active studies for this method."
Answered by AI
Are there any openings available in this experiment for participants?
"The information provided on the clinicaltrials.gov website reveals that this medical trial is not currently recruiting for new participants. It was initially posted on June 1st 2010 and last edited on November 28th 2022, however there are still 2137 other studies actively looking for enrolment at present."
Answered by AI
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