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P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Recruiting
18 years and older
Male
Phase 1
  • Simplified description (AI rewritten)
  • Technical description (Original)

This is an open label, multi-center Phase 1 study that will follow a 3 + 3 design of dose-escalating cohorts of single and multiple doses of P-PSMA-101 to determine a Recommended Phase 2 Dose (RP2D). Additional participants will be treated with P-PSMA-101 at the determined RP2D.

Following consent, enrolled participants will undergo a leukapheresis procedure to obtain peripheral blood mononuclear cells (PBMCs) which will be sent to a manufacturing site to produce P-PSMA-101 CAR-T cells. The cells will then be returned to the investigational site and administered after a lymphodepleting chemotherapy regimen. Rimiducid may be administered as indicated.

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Study details
    Malignant neoplasm of prostate
    Cancer
    Prostatic disorder
    Genitourinary Neoplasms
    Genital Neoplasms
    Male
    Neoplasms by Histologic Type
    Neoplasms by Site
    Prostatic Neoplasms
    Castration-Resistant
    Metastatic Castration-resistant Prostate Cancer

NCT04249947

Poseida Therapeutics, Inc.

19 February 2024

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