TmPSMA-02 in mCRPC

Conditions

• Metastatic Castrate-Resistant Prostate Cancer (mCRPC)

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Jan 31, 2024

Status verified

Dec 2025

Primary completion

Jan 31, 2027

Completion

Jan 31, 2042

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose Level -1
  After lymphodepleting chemotherapy subjects to receive 1x10(7) TmPSMA-02 CAR T Cells
• Experimental: Dose Level 1
  After lymphodepleting chemotherapy subjects to receive 5 x10(7) TmPSMA-02 CAR T Cells
• Experimental: Dose Level 2
  After lymphodepleting chemotherapy subjects to receive 1x10(8) TmPSMA-02 CAR T Cells
• Experimental: Dose Level 3
  After lymphodepleting chemotherapy subjects to receive 3x10(8) TmPSMA-02 CAR T Cells

Primary Outcome Measure

Number of subjects with dose limiting toxicities (DLTs) [ Time Frame: 28 days after TmPSMA-02 CAR T cell infusion ]

Central Contacts

• Abramson Cancer Center Clinical Trials Service
  215-349-8245
  [email protected]

Locations (1)

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