TmPSMA-02 in mCRPC
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
Qualifiers
Signed, written informed consent
Adult participants ≥ 18 years of age
Metastatic castrate-resistant prostate cancer (mCRPC)
Castrate levels of testosterone (<50 ng/dL) with/without the use of androgen-deprivation therapy
Disqualifiers
Active hepatitis B or hepatitis C infection
Any other active, uncontrolled infection
Class III/IV cardiovascular disability according to the New York Heart Association Classification.
Severe, active co-morbidity that in the opinion of the physician-investigator would preclude participation in the study.
Trial design
Treatments tested in this trial
- TmPSMA-02 CAR T Cells
Treatment groups
30 Participants
are divided into 4 treatment groupsSponsors and collaborators
University of Pennsylvania
Lead sponsor
Prostate Cancer Foundation
Collaborator
Source ClinicalTrials.gov