Prostatic Neoplasms, Castration-ResistantPhase 1NCT04249947
P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
A Phase 1 study testing P-PSMA-101 CAR-T cells and Rimiducid in people with Prostatic Neoplasms, Castration-Resistant and Neoplasms by Histologic Type, run by Poseida Therapeutics, Inc. at 10 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostatic Neoplasms, Castration-Resistant, Neoplasms by Histologic Type, Neoplasms, Prostate
- What is being tested?
- P-PSMA-101 CAR-T cells and Rimiducid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 10 sitesUnited States
- Study dates
- 28 Feb 2020to 30 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Massachusetts General Hospital
Boston, Massachusetts, 02215
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
Tennessee Oncology
Nashville, Tennessee, 37203
Tulane University Hospital and Clinic
New Orleans, Louisiana, 70112
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of California San Diego
San Diego, California, 92093
University of California San Francisco
San Francisco, California, 94143
About this study
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)
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.
Read the 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.
- Conditions
- Prostatic Neoplasms, Castration-Resistant, Neoplasms by Histologic Type, Neoplasms, Prostate, Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Neoplasms
- Being tested
- P-PSMA-101 CAR-T cells, Rimiducid
- Keywords
- CAR-T cells, metastatic castration-resistant prostate cancer (mCRPC)
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant, Neoplasms by Histologic Type, Prostatic Neoplasms, Neoplasms, Genital Neoplasms, Male, Urogenital Neoplasms, Neoplasms by Site, Prostatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P-PSMA-101 CAR-T cellsBiological
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).
RimiducidDrug
Rimiducid (safety switch activator) may be administered as indicated
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: P-PSMA-101 CAR-T cells; Drug: Rimiducid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Safety of P-PSMA-101
Incidence and severity of treatment-emergent adverse events
Measured: Baseline through 15 years
Determine the maximum tolerated dose of P-PSMA-101
Rate of dose limiting toxicities (DLT)
Measured: 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).
Measured: Baseline through 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start28 Feb 2020
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Why it stopped: Study closed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Neoplasms, Castration-ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at RP2D
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poseida Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajesh Belani, M.D., Study director, Sponsor Executive Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249947
- Sponsor's protocol ID
- P-PSMA-101-001
- Status last verified
- Jan 2025
- First submitted
- 28 Jan 2020
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04249947
- Acronym / sponsor ID
- P-PSMA-101-001
- Conditions
- Prostatic Neoplasms, Castration-Resistant, Neoplasms by Histologic Type, Neoplasms, Prostate, Prostate Cancer, Metastatic Castration-resistant Prostate Cancer, Neoplasms
- Keywords
- CAR-T cells, metastatic castration-resistant prostate cancer (mCRPC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Poseida Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 31 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at RP2D
| Arm | Type | Receives |
|---|---|---|
| P-PSMA-101 CAR-T cells (Single Dose - Part 1a) | Experimental | Biological: P-PSMA-101 CAR-T cells, Drug: RimiducidSingle 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 (Multiple Dose - Part 1b) | Experimental | Biological: P-PSMA-101 CAR-T cells, Drug: RimiducidCyclic 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 (Single Dose - Part 1c) | Experimental | Biological: P-PSMA-101 CAR-T cells, Drug: RimiducidSingle 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 (Multiple Dose - Part 1d) | Experimental | Biological: P-PSMA-101 CAR-T cells, Drug: RimiducidCyclic administration of ascending dose cohorts, given via intravenous infusions of CAR-T cells, following conditioning chemotherapy regimen B. Rimiducid may be administered as indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| P-PSMA-101 CAR-T cellsP-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). | Biological | 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) |
| RimiducidRimiducid (safety switch activator) may be administered as indicated | Drug | 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) |
Primary outcome
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).
Results and safety
The study was stopped early (reason given: Study closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajesh Belani, M.D. study director
Sponsor Executive Medical Director
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P-PSMA-101 CAR-T cells and Rimiducid in people with Prostatic Neoplasms, Castration-Resistant and Neoplasms by Histologic Type, run by Poseida Therapeutics, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study closed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the Safety of P-PSMA-101 (time frame: Baseline through 15 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.