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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)

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ClinicalTrials.gov Identifier: NCT04249947
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : January 11, 2022
Sponsor:
Information provided by (Responsible Party):
Poseida Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
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 Biological: P-PSMA-101 CAR-T cells Drug: Rimiducid Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at RP2D
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : February 28, 2020
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2036


Arm Intervention/treatment
Experimental: P-PSMA-101 CAR-T cells (Single Dose - Part 1a)
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
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

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

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

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




Primary Outcome Measures :
  1. Assess the Safety of P-PSMA-101 [ Time Frame: Baseline through 15 years ]
    Incidence and severity of treatment-emergent adverse events

  2. Determine the maximum tolerated dose of P-PSMA-101 [ Time Frame: Baseline through Day 28 ]
    Rate of dose limiting toxicities (DLT)

  3. Assess the efficacy of P-PSMA-101 (ORR) [ Time Frame: Baseline through 15 years ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04249947


Contacts
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Contact: Angie Schinkel 858 779 3103 clinicaltrials@poseida.com

Locations
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United States, California
City of Hope Comprehensive Cancer Center Recruiting
Duarte, California, United States, 91010
University of California San Diego Recruiting
San Diego, California, United States, 92093
University of California San Francisco Recruiting
San Francisco, California, United States, 94143
United States, Colorado
Sarah Cannon Research Institute at HealthONE Recruiting
Denver, Colorado, United States, 80218
United States, Maryland
University of Maryland, Baltimore Not yet recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02215
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Sponsors and Collaborators
Poseida Therapeutics, Inc.
Investigators
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Study Director: Matthew Spear, M.D. Sponsor Chief Medical Officer
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Responsible Party: Poseida Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04249947    
Other Study ID Numbers: P-PSMA-101-001
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: January 11, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Poseida Therapeutics, Inc.:
CAR-T cells
metastatic castration-resistant prostate cancer (mCRPC)
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Prostatic Neoplasms
Salivary Gland Neoplasms
Carcinoma, Adenoid Cystic
Carcinoma, Mucoepidermoid
Neoplasms by Site
Neoplasms by Histologic Type
Urogenital Neoplasms
Genital Neoplasms, Male
Prostatic Neoplasms, Castration-Resistant
Carcinoma, Acinar Cell
Prostatic Diseases
Neoplasms, Glandular and Epithelial
Mouth Neoplasms
Head and Neck Neoplasms
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases
Adenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous