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

  • STATUS
    Recruiting
  • End date
    Sep 28, 2036
  • participants needed
    40
  • sponsor
    Poseida Therapeutics, Inc.
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Updated on 19 February 2024
See if I qualify
cancer
measurable disease
metastasis
metastatic disease
metastatic cancer
metastatic castration-resistant prostate cancer
castration-resistant prostate cancer
rimiducid
prostate cancer
metastatic hormone refractory prostate cancer

Summary

An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous CAR-T cells in patients with mCRPC.

Description

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.

Details
Condition 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
Age 18years - 100years
Treatment P-PSMA-101 CAR-T cells, Rimiducid
Clinical Study IdentifierNCT04249947
SponsorPoseida Therapeutics, Inc.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Males 18 years of age
Must have a confirmed diagnosis of mCRPC
Must have measurable disease by RECIST 1.1 or bone only metastases with measurable PSA (1 ng/mL)
Must have progressed by PCWG3 and/or RECIST 1.1
Must have adequate vital organ function within pre-determined parameters
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1

Exclusion Criteria

Has inadequate venous access and/or contraindications to leukapheresis
Has an active second malignancy in addition to mCRPC, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
Has active autoimmune disease
Has a history of significant central nervous system (CNS) disease, such as stroke or epilepsy
Has an active systemic infection
Has received anti-cancer medications (excluding GnRH targeted therapies) within 2 weeks or 5 half-lives (whichever is longer) of the time of initiating conditioning chemotherapy
Has received immunosuppressive medications (including anti-cancer medications) within 2 weeks of initiating leukapheresis and/or expected to require them while enrolled in the study
Has received systemic corticosteroid therapy within 2 weeks of either the required leukapheresis or is expected to require it during the course of the study
Has CNS metastases or symptomatic CNS involvement
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cancer
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castration-resistant prostate cancer
rimiducid
prostate cancer
metastatic hormone refractory prostate cancer

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