Clinical trial NCT04249947: P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
Official title: A Phase 1 Dose Escalation and Expanded Cohort Study of P-PSMA-101 in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: 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
Keywords: CAR-T cells
metastatic castration-resistant prostate cancer (mCRPC)
Lead sponsor: Poseida Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-01-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at RP2D
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 be willing to practice birth control from screening and for 2 years after the last administration of P-PSMA-101
* 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 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 liver metastases (\<5 lesions and maximum diameter \</= 2.5 cm permitted)
* Has a history of or known predisposition to HLH or MAS

Primary outcomes:
measure: Assess the Safety of P-PSMA-101
timeFrame: Baseline through 15 years
measure: Determine the maximum tolerated dose of P-PSMA-101
timeFrame: Baseline through Day 28
measure: Assess the efficacy of P-PSMA-101 (ORR)
timeFrame: Baseline through 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: San Diego
country: United States
facility: University of California San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Denver
country: United States
facility: Sarah Cannon Research Institute at HealthONE
state: Colorado
city: New Orleans
country: United States
facility: Tulane University Hospital and Clinic
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: Sponsor Executive Medical Director
name: Rajesh Belani, M.D.
role: STUDY_DIRECTOR
References: