Clinical Trials /

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

NCT04249947

Description:

An open-label, multi-center, single and cyclic ascending dose study of P-PSMA-101 autologous CAR-T cells in patients with mCRPC.

Related Conditions:
  • Prostate Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1

URL:

https://clinicaltrials.gov/show/NCT04249947

Trial Eligibility

Document

Title

  • Brief Title: P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • Official Title: A Phase 1 Dose Escalation and Expanded Cohort Study of P-PSMA-101 in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Clinical Trial IDs

  • ORG STUDY ID: P-PSMA-101-001
  • NCT ID: NCT04249947

Conditions

  • 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

Interventions

DrugSynonymsArms
P-PSMA-101 CAR-T cellsP-PSMA-101 CAR-T cells (Multiple Dose - Part 1b)
RimiducidP-PSMA-101 CAR-T cells (Multiple Dose - Part 1b)

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
P-PSMA-101 CAR-T cells (Single Dose - Part 1a)ExperimentalSingle 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
  • Rimiducid
P-PSMA-101 CAR-T cells (Multiple Dose - Part 1b)ExperimentalCyclic 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
  • Rimiducid
P-PSMA-101 CAR-T cells (Single Dose - Part 1c)ExperimentalSingle 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
  • Rimiducid
P-PSMA-101 CAR-T cells (Multiple Dose - Part 1d)ExperimentalCyclic 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
  • Rimiducid

Eligibility Criteria

        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
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

Measure:Assess the Safety of P-PSMA-101
Time Frame:Baseline through 15 years
Safety Issue:
Description:Incidence and severity of treatment-emergent adverse events

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Poseida Therapeutics, Inc.

Trial Keywords

  • CAR-T cells
  • metastatic castration-resistant prostate cancer (mCRPC)

Last Updated

April 30, 2021