What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those involving immunotherapy and genetically engineered immune cells like PSCA-CAR T cells, include sipuleucel-T and PD-1/PD-L1 inhibitors. The most common side effects of sipuleucel-T are chills, fatigue, fever, back pain, nausea, joint ache, and headache, which are typically mild and transient. Serious adverse events can include infusion reactions and cerebrovascular events. PD-1/PD-L1 inhibitors may cause fatigue, rash, diarrhea, and immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. These side effects are generally manageable but require close monitoring.

What prior FDA approvals exist?

FDA-approved treatments for prostate cancer include several immunotherapies and targeted therapies. Sipuleucel-T (Provenge) is an FDA-approved autologous cellular immunotherapy for metastatic castration-resistant prostate cancer (CRPC). Pembrolizumab, a PD-1 inhibitor, is approved for metastatic CRPC with specific genetic markers such as dMMR or high TMB. While there are no specific FDA approvals for PSCA-CAR T cells in prostate cancer, ongoing research and trials are exploring the efficacy of CAR T cell therapies targeting prostate-specific antigens.

What other types of research exist?

Promising alternatives to PSCA-CAR T cells for prostate cancer treatment include: 1) VHH-CAR T cells targeting PSMA, which have shown specificity and cytotoxicity against prostate cancer cells. 2) Pembrolizumab, an immune checkpoint inhibitor, which has demonstrated clinical activity in metastatic castration-resistant prostate cancer (mCRPC) in various studies. 3) Atezolizumab, another immune checkpoint inhibitor, which has been evaluated in combination with enzalutamide for mCRPC. These therapies represent advanced immunotherapeutic approaches that could be considered for prostate cancer patients in 2024.

← Back to Search

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

No Placebo-Only Group

Summary

This trial studies the safety and best dose of specially modified immune cells in treating patients with advanced prostate cancer that doesn't respond to standard treatments. The modified immune cells are designed to find and kill cancer cells. The study aims to determine how well this treatment works and its side effects.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Grade 3 Toxicity Profile

Number of Participants Experiencing a Dose-limiting Toxicity (DLT)

Secondary study objectives

Expansion of CAR T Cells

Percent of Participants Achieving Stable Disease

Percent of Participants Alive at Six Months

+1 more

Other study objectives

CAR Immunogenicity

Circulating Free DNA (cfDNA) in Peripheral Blood

Gene Expression

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 4

~1860

Cyclophosphamide

2010

Completed Phase 4

~2310

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for prostate cancer include hormone therapy, chemotherapy, radiation therapy, and immunotherapy. Hormone therapy reduces androgen levels to slow cancer growth, while chemotherapy uses drugs to kill rapidly dividing cells. Radiation therapy targets and destroys cancer cells with high-energy rays. Immunotherapy, such as PSCA-chimeric antigen receptor (CAR) T cells, involves genetically engineering a patient's immune cells to specifically target and kill prostate cancer cells expressing the PSCA antigen. This approach is significant for prostate cancer patients as it offers a personalized treatment option that can potentially improve outcomes by directly targeting cancer cells with minimal impact on healthy tissues.