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

NCT04249947 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: P-PSMA-101-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 10

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.

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)

Outcome Measures

Primary Outcomes (3)

• Assess the Safety of P-PSMA-101

  Incidence and severity of treatment-emergent adverse events

  Baseline through 15 years

• Determine the maximum tolerated dose of P-PSMA-101

  Rate of dose limiting toxicities (DLT)

  Baseline through Day 28

• 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

Study Arms (4)

P-PSMA-101 CAR-T cells (Single Dose - Part 1a)

EXPERIMENTAL

Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen A. Rimiducid may be administered as indicated.

Biological: P-PSMA-101 CAR-T cells; Drug: Rimiducid

P-PSMA-101 CAR-T cells (Multiple Dose - Part 1b)

EXPERIMENTAL

Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen A. Rimiducid may be administered as indicated.

Biological: P-PSMA-101 CAR-T cells; Drug: Rimiducid

P-PSMA-101 CAR-T cells (Single Dose - Part 1c)

EXPERIMENTAL

Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen B. Rimiducid may be administered as indicated.

Biological: P-PSMA-101 CAR-T cells; Drug: Rimiducid

P-PSMA-101 CAR-T cells (Multiple Dose - Part 1d)

EXPERIMENTAL

Cyclic administration of ascending dose cohorts, given via intravenous infusions of CAR-T cells, following conditioning chemotherapy regimen B. Rimiducid may be administered as indicated.

Biological: P-PSMA-101 CAR-T cells; Drug: Rimiducid

Interventions

P-PSMA-101 CAR-T cells BIOLOGICAL

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).

P-PSMA-101 CAR-T cells (Multiple Dose - Part 1b); P-PSMA-101 CAR-T cells (Multiple Dose - Part 1d); P-PSMA-101 CAR-T cells (Single Dose - Part 1a); P-PSMA-101 CAR-T cells (Single Dose - Part 1c)

Rimiducid DRUG

Rimiducid (safety switch activator) may be administered as indicated

P-PSMA-101 CAR-T cells (Multiple Dose - Part 1b); P-PSMA-101 CAR-T cells (Multiple Dose - Part 1d); P-PSMA-101 CAR-T cells (Single Dose - Part 1a); P-PSMA-101 CAR-T cells (Single Dose - Part 1c)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Poseida Therapeutics, Inc.: lead

Study Sites (10)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

University of California San Diego

San Diego, California, 92093, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Sarah Cannon Research Institute at HealthONE

Denver, Colorado, 80218, United States

Location

Tulane University Hospital and Clinic

New Orleans, Louisiana, 70112, United States

Location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02215, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant; Neoplasms by Histologic Type; Prostatic Neoplasms; Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Prostatic Diseases; Salivary Gland Neoplasms; Carcinoma, Adenoid Cystic; Carcinoma, Mucoepidermoid; Carcinoma, Acinar Cell

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Mouth Neoplasms; Head and Neck Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms, Cystic, Mucinous, and Serous

Study Officials

• Rajesh Belani, M.D.

  Sponsor Executive Medical Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at RP2D

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 31, 2020
• Study Start: February 28, 2020
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)