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 |
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Recruitment Status :
Active, not recruiting
First Posted : January 31, 2020
Last Update Posted : November 17, 2022
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Sponsor:
Poseida Therapeutics, Inc.
Information provided by (Responsible Party):
Poseida Therapeutics, Inc.
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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 |
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.
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
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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.
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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 |
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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 :
- Assess the Safety of P-PSMA-101 [ Time Frame: Baseline through 15 years ]Incidence and severity of treatment-emergent adverse events
- Determine the maximum tolerated dose of P-PSMA-101 [ Time Frame: Baseline through Day 28 ]Rate of dose limiting toxicities (DLT)
- 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
Locations
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010 | |
| University of California San Diego | |
| San Diego, California, United States, 92093 | |
| University of California San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Colorado | |
| Sarah Cannon Research Institute at HealthONE | |
| Denver, Colorado, United States, 80218 | |
| United States, Louisiana | |
| Tulane University Hospital and Clinic | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| University of Maryland, Baltimore | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| United States, Tennessee | |
| Tennessee Oncology | |
| Nashville, Tennessee, United States, 37203 | |
Sponsors and Collaborators
Poseida Therapeutics, Inc.
Investigators
| Study Director: | Rajesh Belani, M.D. | Sponsor Executive Medical Director |
| 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: | November 17, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Poseida Therapeutics, Inc.:
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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 Mucoepidermoid Tumor Neoplasms by Site Neoplasms by Histologic Type Urogenital Neoplasms Prostatic Neoplasms, Castration-Resistant Genital Neoplasms, Male Carcinoma, Acinar Cell Prostatic Diseases |
Neoplasms, Glandular and Epithelial Genital Diseases, Male Genital Diseases Urogenital Diseases Male Urogenital Diseases Mouth Neoplasms Head and Neck Neoplasms Mouth Diseases Stomatognathic Diseases Salivary Gland Diseases Adenocarcinoma Neoplasms, Cystic, Mucinous, and Serous Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications |