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CAR T-cell Therapy

CAR T Cells 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).
Must not have
Active autoimmune disease requiring systemic immunosuppressive treatment equivalent to ≥ 10mg of prednisone. Patients with autoimmune neurologic diseases (such as MS) will be excluded
Any other active, uncontrolled infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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%.
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.
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
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I have had treatment for advanced prostate cancer, including hormone therapy or chemotherapy.
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My kidney function is good and I am not on dialysis.
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I have little to no trouble breathing and my oxygen level is above 92% without assistance.
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I am 18 years old or older.
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My testosterone levels are very low, below 50 ng/dL.
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My prostate cancer has spread and is not responding to hormone therapy.
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I have had treatment for advanced prostate cancer, including hormone therapy or chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on strong medication for an autoimmune disease, but I don't have MS.
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I do not have any active, uncontrolled infections.
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I have severe limitations due to heart problems.
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I am allergic to some ingredients in the study medication.
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I have had a stem cell transplant from a donor.

Timeline

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

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

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,053 Previous Clinical Trials
43,013,109 Total Patients Enrolled
8 Trials studying Prostate Cancer
3,997 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
48 Previous Clinical Trials
2,849 Total Patients Enrolled
29 Trials studying Prostate Cancer
1,990 Patients Enrolled for Prostate Cancer
Tceleron Therapeutics, Inc.Industry Sponsor
2 Previous Clinical Trials
17 Total Patients Enrolled
~12 spots leftby Jan 2027
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