Actively Recruiting

Phase 1
Age: 18Years +
MALE
NCT06046040

TmPSMA-02 in mCRPC

Led by University of Pennsylvania · Updated on 2025-12-22

30

Participants Needed

1

Research Sites

939 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

P

Prostate Cancer Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a Phase I, open-label dose finding study to assess the safety, tolerability, manufacturing feasibility, and preliminary efficacy of TmPSMA-02 CAR T cells in patients with metastatic castrate-resistant prostate cancer (mCRPC). Up to 4 total dose levels will be evaluated using a 3+3 dose escalation design.

CONDITIONS

Official Title

TmPSMA-02 in mCRPC

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed, written informed consent
  • Adults aged 18 years or older
  • Diagnosed with metastatic castrate-resistant prostate cancer (mCRPC)
  • Castrate levels of testosterone (<50 ng/dL) with or without androgen-deprivation therapy
  • Received at least one prior systemic therapy for mCRPC, including a second generation androgen receptor inhibitor or taxane-based regimen
  • Adequate organ function within 4 weeks of eligibility confirmation, including:
    • Serum creatinine 64 1.5 mg/dL or creatinine clearance 65 50 cc/min, not on dialysis
    • ALT/AST 64 3 times upper limit of normal
    • Serum total bilirubin 64 1.5 mg/dL (up to 3.0 mg/dL if Gilbert's syndrome)
    • Left ventricle ejection fraction 64 45% by ECHO
    • Pulmonary reserve with 64 Grade 1 dyspnea and pulse oxygen > 92% on room air
  • Adequate hematologic reserve within 4 weeks of eligibility confirmation, including:
    • Hemoglobin 64 8 g/dL
    • Absolute neutrophil count 64 1000/bcL
    • Platelet count 64 75,000/bcL
  • ECOG performance status 0 or 1
  • Patients without bilateral orchiectomy must be able to continue GnRH therapy during the study
  • Participants of reproductive potential must agree to use acceptable birth control methods
Not Eligible

You will not qualify if you...

  • Active hepatitis B or hepatitis C infection
  • Any other active, uncontrolled infection
  • Class III/IV cardiovascular disability per New York Heart Association Classification
  • Severe, active co-morbidity that would preclude study participation
  • Active invasive cancer other than the study cancer within 2 years prior to eligibility (non-invasive cancers treated with curative intent may be allowed)
  • Chronic treatment with systemic steroids or immunosuppressants (low-dose replacement, topical, and inhaled steroids allowed)
  • Prior treatment with autologous T-cell therapy except Sipuleucel-T
  • Prior allogeneic stem cell transplant
  • Active autoimmune disease needing systemic immunosuppressive treatment equivalent to prednisone 65 10 mg (patients with autoimmune neurologic diseases like MS excluded)
  • History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, Dextran 40)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

A

Abramson Cancer Center Clinical Trials Service

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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