P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
NCT ID: NCT04249947
Last Updated: 2025-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
40 participants
INTERVENTIONAL
2020-02-28
2024-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
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).
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated
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.
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).
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated
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.
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).
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated
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.
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).
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated
Interventions
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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).
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Poseida Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rajesh Belani, M.D.
Role: STUDY_DIRECTOR
Sponsor Executive Medical Director
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
University of California San Diego
San Diego, California, United States
University of California San Francisco
San Francisco, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
Tulane University Hospital and Clinic
New Orleans, Louisiana, 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
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Tennessee Oncology
Nashville, Tennessee, United States
Countries
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Other Identifiers
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P-PSMA-101-001
Identifier Type: -
Identifier Source: org_study_id
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