CAR T-Cell Therapy for Prostate Cancer

Overseen by Naomi Haas, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a single center, single arm Phase I study to establish the safety and feasibility of intravenously administered lentivirally transduced dual PSMA-specific/ TGFβ-resistant CAR modified autologous T cells (CART-PSMA-TGFβRDN cells) in patients with metastatic castrate resistant prostate cancer.

Research Team

Naomi Haas, MD

Principal Investigator

Universtiy of Pennsylvania

Eligibility Criteria

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.

Inclusion Criteria

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 have had treatment for advanced prostate cancer that no longer responds to hormonal therapy.

Exclusion 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.

I haven't had immune therapy for cancer in the last 2 months, except for cancer vaccines.

Treatment Details

Interventions

• CART-PSMA-TGFβRDN cells (CAR T-cell Therapy)

Trial Overview 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.

Participant Groups

Group I: Cohort 4 Experimental Treatment 3 Interventions

CART-PSMA-TGFβRDN cells 0.70-1.00 x 10\^8 Day 0

Group II: Cohort 3 Experimental Treatment 3 Interventions

CART-PSMA-TGFβRDN cells at the MTD (established by Cohorts 1-2) on day 0

Group III: Cohort 2 Experimental Treatment 1 Intervention

CART-PSMA-TGFβRDN cells 1-3x10\^8 Day 0

Group IV: Cohort 1 Experimental Treatment 1 Intervention

CART-PSMA-TGFβRDN cells 1-3x10\^7 Day 0

Group V: Cohort -3 Experimental Treatment 3 Interventions

CART-PSMA-TGFβRDN cells 1-3x10\^7 Day 0

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Dr. Joan Lau

University of Pennsylvania

Chief Executive Officer since 2020

PhD in Neuroscience from the University of Cincinnati College of Medicine, MBA from the Wharton School of Business, BS in Bioengineering from the University of Pennsylvania

Dr. Robert Iannone

University of Pennsylvania

Chief Medical Officer since 2019

MD from Yale University, MSCE from the University of Pennsylvania