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

Prostate Cancer Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04249947
• Other study ID #: P-PSMA-101-001
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 28, 2020
• Est. completion date: September 2036

Study information

• Verified date: April 2024
• Source: Poseida Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 2036
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoid Cystic Carcinoma
• Carcinoma
• Carcinoma, Adenoid Cystic
• Genital Neoplasms, Male
• Metastatic Castration-resistant Prostate Cancer
• Mucoepidermoid Carcinoma
• Neoplasms
• Neoplasms by Histologic Type
• Neoplasms by Site
• Neoplasms, Prostate
• Prostate Cancer
• Prostatic Disease
• Prostatic Diseases
• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant
• Salivary Duct Carcinoma
• Salivary Gland Cancer
• Salivary Gland Neoplasms
• Salivary Gland Tumor
• Urogenital Neoplasms

Intervention

Biological:
• P-PSMA-101 CAR-T cells
P-PSMA-101 is an autologous chimeric antigen receptor (CAR) T-cell therapy designed to target prostate cancer cells expressing the cell surface antigen prostate-specific membrane antigen (PSMA).

Drug:
• Rimiducid
Rimiducid (safety switch activator) may be administered as indicated

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Sarah Cannon Research Institute at HealthONE	Denver	Colorado
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Tennessee Oncology	Nashville	Tennessee
United States	Tulane University Hospital and Clinic	New Orleans	Louisiana
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	University of California San Diego	San Diego	California
United States	University of California San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Poseida Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the Safety of P-PSMA-101	Incidence and severity of treatment-emergent adverse events	Baseline through 15 years
Primary	Determine the maximum tolerated dose of P-PSMA-101	Rate of dose limiting toxicities (DLT)	Baseline through Day 28
Primary	Assess the efficacy of P-PSMA-101 (ORR)	According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST), and Prostate Cancer Response assessed by Prostate Cancer Working Group 3 (PCWG3) criteria: Overall Response Rate (ORR)-Percentage of patients with complete response (CR) or partial response (PR).	Baseline through 15 years