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CAR T-cell Therapy
CAR T-Cell Therapy for Prostate Cancer
Phase 1
Recruiting
Led By Naomi Haas, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥10% tumor cells expressing PSMA as demonstrated by immunohistochemistry analysis on biopsied tissue
Radiographic evidence of osseous metastatic disease and/or measurable, non-osseous metastatic disease (nodal or visceral)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 years
Awards & highlights
Study Summary
This trial is to study a new cancer treatment and to see if it is safe and works well.
Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has spread, showing at least 10% of tumor cells expressing PSMA. They should be relatively healthy (ECOG status 0-1), have good organ function, no severe heart issues or active infections like hepatitis B/C or HIV, not on high-dose steroids, and haven't had more than four prior treatments for this cancer stage.Check my eligibility
What is being tested?
The trial is testing a new type of cell therapy where the patient's own immune cells are modified to target prostate cancer cells better. These special CART-PSMA-TGFβRDN cells are given through an IV after preparing the body with drugs Fludarabine and Cyclophosphamide.See study design
What are the potential side effects?
Possible side effects include reactions related to the infusion process, increased risk of infection due to immune system changes, potential liver problems indicated by blood tests, fatigue from treatment-related anemia or other blood count changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor shows high PSMA levels on a biopsy.
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My cancer has spread to my bones or other parts of my body and can be seen on scans.
Select...
My kidney and liver functions are within normal ranges.
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My prostate cancer is worsening despite low testosterone levels.
Select...
I have had treatment for advanced prostate cancer that no longer responds to hormonal therapy.
Select...
My prostate cancer has spread and is not responding to hormone therapy.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinical feasibility is defined as the frequency of subjects enrolled on this protocol who do not receive CART-PSMA-TGFβRDN cells.
Manufacturing feasibility is determined by the frequency of product release failures and the occurrence of dose failures (inability to meet target dose).
Occurrence of study related adverse events, laboratory toxicities and clinical events that are possibly, likely, or definitely related to study participation.
Secondary outcome measures
Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by PCWG2
Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by RECIST
Assess the clinical anti-tumor effect of CART-PSMA-TGFβRDN cells by number of subjects with progression free survival (PFS).
+2 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment3 Interventions
CART-PSMA-TGFβRDN cells 0.70-1.00 x 10^8 Day 0
Group II: Cohort 3Experimental Treatment3 Interventions
CART-PSMA-TGFβRDN cells at the MTD (established by Cohorts 1-2) on day 0
Group III: Cohort 2Experimental Treatment1 Intervention
CART-PSMA-TGFβRDN cells 1-3x10^8 Day 0
Group IV: Cohort 1Experimental Treatment1 Intervention
CART-PSMA-TGFβRDN cells 1-3x10^7 Day 0
Group V: Cohort -3Experimental Treatment3 Interventions
CART-PSMA-TGFβRDN cells 1-3x10^7 Day 0
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
FDA approved
Cyclophosphamide
FDA approved
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,190 Total Patients Enrolled
6 Trials studying Prostate Cancer
2,674 Patients Enrolled for Prostate Cancer
Naomi Haas, MDPrincipal InvestigatorUniverstiy of Pennsylvania
2 Previous Clinical Trials
39 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart problems as defined by the NYHA.I do not have a condition that increases risk of severe immune or nerve side effects.My tumor shows high PSMA levels on a biopsy.My cancer has spread to my bones or other parts of my body and can be seen on scans.I haven't had immune therapy for cancer in the last 2 months, except for cancer vaccines.I have had a cancer other than prostate cancer that was not cured, within the last 3 years.My PSA levels are increasing, but I have no signs of cancer spread on scans.I am on a low dose of steroids, not more than 10mg of prednisone daily.I have had more than 4 treatments for advanced prostate cancer.I have spinal cord issues due to cancer spread to my spine.I have an active autoimmune disease or a history of severe autoimmune disease.I do not have active hepatitis B, C, or HIV.I have had treatment for advanced prostate cancer that no longer responds to hormonal therapy.My kidney and liver functions are within normal ranges.My prostate cancer is worsening despite low testosterone levels.My blood counts are within the required range and I don't need blood transfusions.My prostate cancer has spread and is not responding to hormone therapy.I am fully active or can carry out light work.I am 18 years old or older.I currently have an infection.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2
- Group 2: Cohort 3
- Group 3: Cohort -3
- Group 4: Cohort 4
- Group 5: Cohort 1
Awards:
This trial has 3 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
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.
What applications do CART-PSMA-TGFβRDN cells typically facilitate?
"Patients with multiple sclerosis, mixed-cell type lymphoma, and acute myelocytic leukemia can be treated using CART-PSMA-TGFβRDN cells."
Answered by AI
Can new participants still join this experiment?
"Affirmative, the clinical trial information posted to clinicaltrials.gov shows that this medical experiment is still searching for participants since its initial launch on March 8th 2017. 19 individuals are needed from a single site before recruitment ends and last edits were made on March 17th 2022."
Answered by AI
What experiments have been done to evaluate the effectiveness of CART-PSMA-TGFβRDN cells?
"Presently, 816 individual research studies are being conducted with CART-PSMA-TGFβRDN cells. Of these investigations, 154 have progressed to Phase 3 clinical trials. Though Philadelphia is the hub for studying this treatment, there exist 27827 sites running such experiments worldwide."
Answered by AI
Are CART-PSMA-TGFβRDN cells an innocuous option for individuals seeking medical treatment?
"Limited data on CART-PSMA-TGFβRDN cells' efficacy and safety warrants a score of 1."
Answered by AI
How many participants is this research endeavor accommodating?
"Affirmative. The information posted on clinicaltrials.gov reveals that this research is still open to applicants, with the initial posting being made on March 8th 2017 and last updated on March 17th 2022. 19 individuals are sought at one study location."
Answered by AI
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