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CAR T-cell Therapy

Dose Expansion for Prostate Cancer

Phase 1

Recruiting

Led By Daniel Abate-Daga, MD, PhD

Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Prior therapies with at least 2 lines of chemotherapy and one new androgen receptor targeted therapy (abiraterone, enzalutamide, apalutamide, or darolutamide)

ECOG performance status less than or equal to 2 (or Karnofsky Performance Status greater than or equal to 70%)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is for patients with advanced prostate cancer that has spread to other parts of the body. The trial will test a new treatment using modified immune cells to target the cancer cells. The goal is to

Who is the study for?

This trial is for individuals with advanced prostate cancer that has spread and resisted treatment, who are currently on zoledronate for bone metastases. It's designed to find out if a new therapy using the patient's own modified T cells can safely target cancer cells.Check my eligibility

What is being tested?

The study tests autologous T cells (the patient's own immune cells) that have been genetically altered to attack prostate cancer by targeting Prostate Stem Cell Antigen. The trial includes initial phases to determine safe dosage levels and later phases to evaluate how well these modified T cells work.See study design

What are the potential side effects?

Potential side effects may include reactions related to Fludarabine and Cyclophosphamide such as nausea, fatigue, low blood cell counts leading to increased infection risk, liver or kidney issues. The modified T cell therapy could also cause immune system-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had 2 chemotherapy treatments and 1 hormone therapy for my cancer.

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I am mostly self-sufficient and can carry out daily activities.

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I am a man aged 18 or older.

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I haven't had any cancer treatments like chemotherapy or radiation in the last 3 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Tolerated Dose (MTD) of MSGV1-PSCA-8T28Z

Secondary outcome measures

Best Prostate Specific Antigen (PSA) Response rate

Percentage of circulating tumor cell count conversion from above 5/ml to below 5/ml.

Radiographic progression-free survival (rPFS)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Dose ExpansionExperimental Treatment3 Interventions

Participants will undergo leukapheresis followed by lymphodepletion and infusion of MSGV1-PSCA-8T28Z. Lymphodepletion will include 3 days of treatment with fludarabine (30 mg/m^2) and cyclophosphamide (500 mg/m^2) prior to study day 0. Participants will then receive MSGV1-PSCA-8T28Z at the dose level determined to be the Maximum Tolerated Dose (MTD) in the dose escalation portion of the study.

Group II: Dose EscalationExperimental Treatment3 Interventions

Participants will undergo leukapheresis followed by lymphodepletion and infusion of MSGV1-PSCA-8T28Z. The lymphodepletion regimen includes cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) administered over 3 days (Days -5, -4, -3). The standard "3+3" design will be used to guide dose escalation/de-escalation decisions based on the cumulative number of patients who experience a dose limiting toxicity (DLT) at the current dose. The first cohort of 3 patients will be treated at dose level 1. The target maximum doses infused at each dose level is: Dose Level 1: 1x10^5 cells/kg Dose Level 2: 3x10^5 cells/kg Dose Level 3: 1x10^6 cells/kg Dose Level 4: 3x10^6 cells/kg Dose Level 5: 1x10^6 cells/kg

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,452 Total Patients Enrolled

28 Trials studying Prostate Cancer

4,184 Patients Enrolled for Prostate Cancer

Daniel Abate-Daga, MD, PhDPrincipal InvestigatorMoffitt Cancer Center

Jingsong Zhang, MD, PhDPrincipal InvestigatorMoffitt Cancer Center

2 Previous Clinical Trials

57 Total Patients Enrolled

2 Trials studying Prostate Cancer

57 Patients Enrolled for Prostate Cancer

Frequently Asked Questions

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

Is the enrollment for this study currently open?

"Apologies for the confusion. As indicated on clinicaltrials.gov, this particular trial is no longer actively seeking candidates. It was initially posted on February 1st, 2024 and last updated on January 4th, 2024. However, there are currently 1215 other ongoing clinical trials that are actively recruiting patients at this time."

Answered by AI

What level of risk does Dose Expansion pose to individuals?

"Given the limited available data supporting safety and efficacy, our team at Power rates Dose Expansion with a score of 1 on a scale from 1 to 3. This is because it is classified as a Phase 1 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC

2024. "Autologous Gamma Delta T Cells to Target Prostate Stem Cell Antigen in mCRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06193486.

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