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CAR T-cell Therapy

CAR T Cell Therapy for Prostate Cancer

Phase 1
Waitlist Available
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 up to 1 year post treatment
Awards & highlights

Study Summary

This trial is testing how safe and effective it is to give patients with metastatic prostate cancer PSCA-CAR T cells, which are immune cells that have been engineered to kill prostate tumor cells.

Who is the study for?
Men with advanced prostate cancer that's resistant to hormone therapy and has spread, who are fit enough for treatment (ECOG 0-2), have PSCA+ tumors, and can consent. They must not have certain central nervous system conditions, uncontrolled infections, HIV/hepatitis B/C, bleeding disorders or recent strokes. Participants need proper liver/kidney function and agree to birth control during the study.Check my eligibility
What is being tested?
The trial is testing a new type of immune cell therapy called PSCA-CAR T cells on men with metastatic castration-resistant prostate cancer. These cells are genetically modified to attack prostate cancer cells by recognizing a specific antigen present on their surface.See study design
What are the potential side effects?
Potential side effects may include reactions related to the infusion of CAR T-cells such as fever, fatigue, headache; risk of infection; possible damage to non-cancerous cells that share the targeted antigen; and other immune-related effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Grade 3 Toxicity Profile
Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
Secondary outcome measures
Expansion of CAR T Cells
Percent of Participants Achieving Stable Disease
Percent of Participants Alive at Six Months
+1 more
Other outcome measures
CAR Immunogenicity
Circulating Free DNA (cfDNA) in Peripheral Blood
Gene Expression
+2 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (PSCA CAR T cells)Experimental Treatment4 Interventions
Patients may receive lymphodepleting regimen (either standard or modified) including fludarabine IV on days -5 to -3 and cyclophosphamide IV on days -5 to -3 or on days -4 and/or -3. The study PI and the protocol team will choose a chemotherapy regimen, for lymphodepletion prior to the PSCA-CAR T cell infusion (with the exception of cohorts 1 and -1 which will not receive lymphodepletion), based on the research participant's disease type and prior therapies. Patients then receive autologous anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T lymphocytes IV over 10-15 minutes at day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine
2012
Completed Phase 3
~1100
Cyclophosphamide
1995
Completed Phase 3
~3770
Fludarabine Phosphate
1997
Completed Phase 3
~2390

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,446 Total Patients Enrolled
14 Trials studying Prostate Cancer
5,613 Patients Enrolled for Prostate Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,653 Total Patients Enrolled
561 Trials studying Prostate Cancer
507,173 Patients Enrolled for Prostate Cancer
Tanya B DorffPrincipal InvestigatorCity of Hope Medical Center
3 Previous Clinical Trials
121 Total Patients Enrolled

Media Library

PSCA-CAR T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03873805 — Phase 1
Prostate Cancer Research Study Groups: Treatment (PSCA CAR T cells)
Prostate Cancer Clinical Trial 2023: PSCA-CAR T Cells Highlights & Side Effects. Trial Name: NCT03873805 — Phase 1
PSCA-CAR T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03873805 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks do Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes pose for people?

"Our team at Power estimates that Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes is relatively safe, scoring a 1 on the risk scale. This Phase 1 trial provides limited evidence for efficacy and safety."

Answered by AI

Is it still possible to join this research project?

"According to the information on clinicaltrials.gov, this research project is open for enrollment and was initially posted August 20th 2019 before being updated most recently on March 17th 2022."

Answered by AI

How is Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes typically utilized?

"Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t expressing T lymphocytes can be employed to treat a variety of ailments, including multiple sclerosis, mixed cell type lymphoma and myelocytic acute leukemia."

Answered by AI

What is the participant count for this research endeavor?

"Affirmative. Clinicaltrials.gov contains data that reflects this clinical trial's active recruitment status, which began on the 20th of August 2019 and latest edit was made on 17 March 2022. 33 participants are required for enrolment across a single site."

Answered by AI

What are the desired results of this medical investigation?

"This clinical trial will primarily measure the full toxicity profile of participants over a 28 day period post-treatment. Secondary objectives include assessing CAR T cell persistence, expansion and serum cytokine profiles to gauge potential CRS side effects and monitor CAR T effector function."

Answered by AI

What have prior experiments yielded with regards to Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes?

"As of now, 889 clinical trials focusing on Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes have been initiated. Of these, 161 are currently in Phase 3 testing and the majority are located in Philadelphia, PA with 28443 other participating sites across the world."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer
2019. "PSCA-CAR T Cells in Treating Patients With PSCA+ Metastatic Castration Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03873805.
~2 spots leftby Apr 2025
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