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CAR T-cell Therapy
CAR-T Cells +/− Radiation for Prostate Cancer
Phase 1
Recruiting
Led By Tanya B Dorff
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post chimeric antigen receptor (car) t cell infusion up to 15 years
Awards & highlights
Study Summary
This trial tests a new treatment for advanced prostate cancer that uses T-cell therapy and radiation.
Who is the study for?
This trial is for men aged 18+ with metastatic castration-resistant prostate cancer that has spread and shows PSCA protein presence. They must have adequate organ function, no severe allergies to study agents, no active infections or bleeding disorders, not be HIV or hepatitis B/C positive, and agree to birth control measures.Check my eligibility
What is being tested?
The trial tests the safety and optimal dose of modified immune cells (PSCA-CAR T-cells) designed to target prostate cancer cells, given with or without radiation therapy. It aims to see if these treatments can better eliminate tumors in patients whose prostate cancer continues growing despite hormone therapy.See study design
What are the potential side effects?
Potential side effects include reactions related to the infusion of CAR T-cells such as fever, fatigue, blood pressure changes; complications from radiation like skin irritation; plus risks associated with bone marrow suppression leading to increased infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post chimeric antigen receptor (car) t cell infusion up to 15 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post chimeric antigen receptor (car) t cell infusion up to 15 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
50% prostate specific antigen (PSA) level reduction
Incidence of adverse events
Secondary outcome measures
Disease response by PSA
Disease response by Prostate Cancer Working Group criteria
Disease response by immune-modified Response Evaluation Criteria in Solid Tumors criteria
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Treatment plan II (PSCA CAR T-cells, radiation)Experimental Treatment8 Interventions
Patients undergo leukapheresis, radiation in 2 doses, and lymphodepletion, and receive PSCA-CAR T cells IV up to 3 times on study. Patients undergo bone scan, CT scan, tumor biopsy, and collection of blood, stool, and urine samples throughout the trial.
Group II: Treatment plan I (PSCA CAR T-cells)Experimental Treatment7 Interventions
Patients undergo leukapheresis and lymphodepletion and receive PSCA-CAR T cells IV up to 3 times on study. Patients undergo bone scan, CT scan, tumor biopsy, and collection of blood, stool, and urine samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Computed Tomography
2017
Completed Phase 2
~2720
Biospecimen Collection
2004
Completed Phase 2
~1700
Leukapheresis
2016
Completed Phase 2
~690
External Beam Radiation Therapy
2006
Completed Phase 3
~3070
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,672 Previous Clinical Trials
40,926,420 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,095 Patients Enrolled for Prostate Cancer
City of Hope Medical CenterLead Sponsor
567 Previous Clinical Trials
1,922,639 Total Patients Enrolled
14 Trials studying Prostate Cancer
5,613 Patients Enrolled for Prostate Cancer
Tanya B DorffPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
114 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have not had a stroke or brain bleed in the last 6 months.I have a history of optic neuritis or other immune-related brain diseases.I had cancer before, but it was either removed surgically with the aim of curing it, or it was a minor skin cancer, or a non-invasive bladder cancer, and I've been free of active disease for 3 years.My prostate cancer is resistant to hormonal therapy.My heart rhythm problem is not controlled by medication.I have a bleeding disorder like von Willebrand's disease or hemophilia.My tumor tested positive for PSCA.My prostate cancer is worsening, shown by rising PSA levels or new cancer spots on scans.I am currently using steroids or immunosuppressant medications regularly.I have a history of HIV or hepatitis B/C.I am currently taking antibiotics for an infection.I agree to use birth control or abstain from sex during and for 3 months after the study.I am mostly active and can care for myself.I have recovered from side effects of previous cancer treatment.I have a serious health condition that is not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment plan II (PSCA CAR T-cells, radiation)
- Group 2: Treatment plan I (PSCA CAR T-cells)
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.
Is enrollment in this experiment currently available?
"According to clinicaltrials.gov, this experiment is not actively enrolling participants at the moment; in fact, it was last updated on April 5th 2023. Although this trial has reached its recruitment capacity, 3673 other trials are available for patients seeking medical intervention now."
Answered by AI
What can be inferred about the security of utilizing Treatment Plan I (PSCA CAR T-cells) on humans?
"Our internal data analysis at Power gives Treatment plan I (PSCA CAR T-cells) a score of 1 on the safety scale as it is only in Phase 1 trials and thus has limited evidence for both efficacy and security."
Answered by AI
What is the primary ambition of this research effort?
"This long-term clinical trial, monitored for up to 15 years post CAR T cell infusion, aims to reduce PSA levels by 50%. Secondary goals include quantifying the peak expansion of CAR T cells according to treatment plan, assessing PSCA expression on tumor cells through IHC/flow cytometry and analyzing serum cytokine profiles with statistical methods."
Answered by AI
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