← Back to Search

CAR T-cell Therapy

Dose Level 2 for Prostate Cancer

Phase 1

Recruiting

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

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

Must have

Adequate organ function within 4 weeks of eligibility confirmation by a physician-investigator defined as: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 cc/min per the Cockcroft-Gault Equation; Patient must not be on dialysis, ALT/AST ≤ 3 x ULN, Serum total bilirubin ≤ 1.5 mg/dL, unless the subject has Gilbert's syndrome (if so, serum total bilirubin must be ≤3.0 mg/dL), Left Ventricle Ejection Fraction (LVEF) ≥ 45% confirmed by ECHO, Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen > 92% on room air, Patients must have adequate hematologic reserve within 4 weeks of eligibility confirmation by a physician-investigator and must not be dependent on transfusions to maintain these hematologic parameters. Adequate hematologic reserve is defined as: Hemoglobin ≥ 8 g/dL, Absolute neutrophil count ≥ 1000/μL, Platelet count ≥ 75,000/μL, ECOG Performance Status that is either 0 or 1, Patients who have not undergone bilateral orchiectomy must be able to continue GnRH therapy during the study, Participants of reproductive potential must agree to use acceptable birth control methods, as described in the protocol

Received at least one prior standard therapy for systemic treatment in the mCRPC setting, including at least one second generation androgen receptor signaling inhibitor (e.g., enzalutamine, apalutamide, darolutamide, or abiraterone) or a taxane-based regimen (e.g., docetaxel, cabazitaxel, etc).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to one year

Awards & highlights

Study Summary

This trial is testing a new treatment called TmPSMA-02 CAR T cells in patients with advanced prostate cancer. The study will look at how safe and effective the treatment is at different doses.

Who is the study for?

This trial is for adults over 18 with advanced prostate cancer that's resistant to hormone therapy. They must have tried at least one standard treatment, including androgen receptor inhibitors or taxane-based chemo. Participants need normal liver function, kidney function (not on dialysis), and a healthy heart with an ejection fraction of at least 45%.Check my eligibility

What is being tested?

The study tests different doses of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer. It's an early-phase trial to see if the treatment is safe, tolerable, can be made reliably, and works against this type of cancer using a step-by-step dose increase method.See study design

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical reactions related to CAR T cell therapies such as fever, fatigue, immune system reactions, and issues affecting blood pressure or breathing.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have had treatment for advanced prostate cancer, including hormone therapy or chemotherapy.

Select...

My kidney function is good and I am not on dialysis.

Select...

I have little to no trouble breathing and my oxygen level is above 92% without assistance.

Select...

I am 18 years old or older.

Select...

My testosterone levels are very low, below 50 ng/dL.

Select...

My prostate cancer has spread and is not responding to hormone therapy.

Select...

I have had treatment for advanced prostate cancer, including hormone therapy or chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to one year

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

Treatment Details

Study Objectives

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

Primary outcome measures

Determination of maximum tolerated dose (MTD)

Incidence of Adverse Events as assessed by CTCAE v5.0

Number of subjects with dose limiting toxicities (DLTs)

Secondary outcome measures

Duration of Response (DOR)

Overall Response Rate (ORR)

Overall Survival (OS)

+3 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Level 3Experimental Treatment1 Intervention

After lymphodepleting chemotherapy subjects to receive 3x10(8) TmPSMA-02 CAR T Cells

Group II: Dose Level 2Experimental Treatment1 Intervention

After lymphodepleting chemotherapy subjects to receive 1x10(8) TmPSMA-02 CAR T Cells

Group III: Dose Level 1Experimental Treatment1 Intervention

After lymphodepleting chemotherapy subjects to receive 5 x10(7) TmPSMA-02 CAR T Cells

Group IV: Dose Level -1Experimental Treatment1 Intervention

After lymphodepleting chemotherapy subjects to receive 1x10(7) TmPSMA-02 CAR T Cells

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Prostate Cancer FoundationOTHER

47 Previous Clinical Trials

2,762 Total Patients Enrolled

28 Trials studying Prostate Cancer

1,930 Patients Enrolled for Prostate Cancer

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,269 Total Patients Enrolled

7 Trials studying Prostate Cancer

2,697 Patients Enrolled for Prostate Cancer

Tceleron Therapeutics, Inc.Industry Sponsor

2 Previous Clinical Trials

17 Total Patients Enrolled

Frequently Asked Questions

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

Has the dosage level known as -1 received approval from the FDA?

"Based on the nature of this Phase 1 trial, our team at Power rates the safety of Dose Level -1 with a score of 1. The available data supporting both safety and efficacy is limited in this early stage."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical investigation?

"Indeed, information from clinicaltrials.gov confirms that this research is currently seeking participants. Initially shared on January 31st, 2024, the latest update was made on February 2nd of the same year. The trial aims to recruit a total of 18 patients from a single site."

Answered by AI

Is the enrollment process currently open for this clinical trial?

"As per the details available on clinicaltrials.gov, this trial is actively seeking participants. It was initially listed on January 31st, 2024 and last revised on February 2nd, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TmPSMA-02 in mCRPC

2024. "TmPSMA-02 in mCRPC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046040.