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Trial record 1 of 1 for:    P-PSMA-101
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P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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ClinicalTrials.gov Identifier: NCT04249947
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : November 19, 2020
Sponsor:
Information provided by (Responsible Party):
Poseida Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE January 28, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date November 19, 2020
Actual Study Start Date  ICMJE February 28, 2020
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 29, 2020)
  • 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 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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Official Title  ICMJE A Phase 1 Dose Escalation and Expanded Cohort Study of P-PSMA-101 in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Biological: P-PSMA-101 CAR-T cells
    • Drug: Rimiducid
  • 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.
    Interventions:
    • Biological: P-PSMA-101 CAR-T cells
    • Drug: Rimiducid
  • 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.
    Interventions:
    • Biological: P-PSMA-101 CAR-T cells
    • Drug: Rimiducid
  • 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.
    Interventions:
    • Biological: P-PSMA-101 CAR-T cells
    • Drug: Rimiducid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 29, 2020)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2036
Estimated Primary Completion Date September 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males ≥18 years of age
  • Must have a confirmed diagnosis of mCRPC
  • Must have measurable disease by RECIST 1.1 or bone only metastases with measurable PSA (≥1 ng/mL)
  • Must have progressed by PCWG3 and/or RECIST 1.1
  • 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, 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 or 5 half-lives (whichever is longer) 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
  • Has a history of or known predisposition to HLH or MAS
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Angie Schinkel 858 779 3103 clinicaltrials@poseida.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04249947
Other Study ID Numbers  ICMJE P-PSMA-101-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Poseida Therapeutics, Inc.
Study Sponsor  ICMJE Poseida Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Boyan Litchev, M.D. Sponsor Executive Medical Director
PRS Account Poseida Therapeutics, Inc.
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP