Health TrialsbyHealthPanel

TmPSMA-02 in mCRPC

ConditionMetastatic Castrate-Resistant Prostate Cancer (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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • TmPSMA-02 CAR T Cells

    Drug

    TmPSMA-02 CAR T cells: autologous T cells transduced with a lentiviral vector to express an anti-PSMA CAR containing a humanized J591-derived scFv and CD2 co-stimulatory domain, and dually armored with a TGFβRDN and PD1.CD28 switch receptor.

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: Dose Level -1Experimental treatment 1 intervention
Group B: Dose Level 1Experimental treatment 1 intervention
Group C: Dose Level 2Experimental treatment 1 intervention
Group D: Dose Level 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of subjects with dose limiting toxicities (DLTs)

Time frame
28 days after TmPSMA-02 CAR T cell infusion
2

Determination of maximum tolerated dose (MTD)

Time frame
28 days after TmPSMA-02 CAR T cell infusion
3

Incidence of Adverse Events as assessed by CTCAE v5.0

Time frame
Up to 15 years

Secondary outcomes

1

Percentage of manufacturing products that meet release criteria

Time frame
Up to 3 years
2

Overall Response Rate (ORR)

Time frame
Up to 3 months
3

Duration of Response (DOR)

Time frame
up to one year
4

Progression Free Survival (PFS)

Time frame
Up to one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Prostate Cancer Foundation

Collaborator

Source ClinicalTrials.gov
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