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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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and post chimeric antigen receptor (car) t cell infusion up to 15 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

50% prostate specific antigen (PSA) level reduction

Incidence of adverse events

Secondary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

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

Trial 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

Computed Tomography

2017

Completed Phase 2

~2740

Biopsy

2014

Completed Phase 4

~1090