P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)

STATUS

Recruiting
End date

Sep 30, 2036
participants needed

60
sponsor

Poseida Therapeutics, Inc.

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Updated on 30 June 2022

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cancer

metastatic disease

measurable disease

metastasis

castration-resistant prostate cancer

primary cancer

metastatic cancer

metastatic castration-resistant 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 and SGC.

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	Prostatic Neoplasms, Castration-Resistant, Neoplasms by Histologic Type, Neoplasms, Prostate, Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Neoplasms, Prostatic Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Prostatic Disease, Salivary Gland Cancer, Salivary Gland Tumor, Adenoid Cystic Carcinoma, Salivary Duct Carcinoma, Mucoepidermoid Carcinoma, Acinic Cell Tumor
Treatment	Rimiducid, P-PSMA-101 CAR-T cells
Clinical Study Identifier	NCT04249947
Sponsor	Poseida Therapeutics, Inc.
Last Modified on	30 June 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Subjects ≥18 years of age
	Must have a confirmed diagnosis of mCRPC or SGC
	Must have measurable disease by RECIST 1.1 or bone only metastases with measurable PSA (≥1 ng/mL) (mCRPC subjects only)
	Must have progressed by PCWG3 and/or RECIST 1.1 (mCRPC subjects only)
	Must have adequate vital organ function within pre-determined parameters
	Must be willing to practice birth control from screening and for 2 years after the last administration of P-PSMA-101
	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 or SGC, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
	Has a history of or active autoimmune disease
	Has a history of significant central nervous system (CNS) disease, such as stroke or epilepsy
	Has an active systemic (viral, bacterial or fungal) infection
	Has received anti-cancer medications (excluding GnRH targeted therapies) within 2 weeks 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
	Has a history of significant ocular disease
	Has a history of significant liver disease or active liver disease
	Has a history of or known predisposition to HLH or MAS
	Has liver metastases (<5 lesions and maximum diameter </= 2.5 cm permitted)

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P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)