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P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)

Primary Purpose

Prostatic Neoplasms, Castration-Resistant, Neoplasms by Histologic Type, Neoplasms, Prostate

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
P-PSMA-101 CAR-T cells
Rimiducid
Sponsored by
Poseida Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms, Castration-Resistant focused on measuring CAR-T cells, metastatic castration-resistant prostate cancer (mCRPC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • City of Hope Comprehensive Cancer Center
  • University of California San Diego
  • University of California San Francisco
  • Sarah Cannon Research Institute at HealthONE
  • Tulane University Hospital and Clinic
  • University of Maryland, Baltimore
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Memorial Sloan Kettering Cancer Center
  • Tennessee Oncology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

P-PSMA-101 CAR-T cells (Single Dose - Part 1a)

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

P-PSMA-101 CAR-T cells (Single Dose - Part 1c)

P-PSMA-101 CAR-T cells (Multiple Dose - Part 1d)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Assess the Safety of P-PSMA-101
Incidence and severity of treatment-emergent adverse events
Determine the maximum tolerated dose of P-PSMA-101
Rate of dose limiting toxicities (DLT)
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).

Secondary Outcome Measures

Full Information

First Posted
January 28, 2020
Last Updated
November 15, 2022
Sponsor
Poseida Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04249947
Brief Title
P-PSMA-101 CAR-T Cells in the Treatment of Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Advanced Salivary Gland Cancers (SGC)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poseida Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
CAR-T cells, metastatic castration-resistant prostate cancer (mCRPC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at RP2D
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P-PSMA-101 CAR-T cells (Single Dose - Part 1a)
Arm Type
Experimental
Arm Description
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.
Arm Title
P-PSMA-101 CAR-T cells (Multiple Dose - Part 1b)
Arm Type
Experimental
Arm Description
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.
Arm Title
P-PSMA-101 CAR-T cells (Single Dose - Part 1c)
Arm Type
Experimental
Arm Description
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.
Arm Title
P-PSMA-101 CAR-T cells (Multiple Dose - Part 1d)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
P-PSMA-101 CAR-T cells
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Rimiducid
Intervention Description
Rimiducid (safety switch activator) may be administered as indicated
Primary Outcome Measure Information:
Title
Assess the Safety of P-PSMA-101
Description
Incidence and severity of treatment-emergent adverse events
Time Frame
Baseline through 15 years
Title
Determine the maximum tolerated dose of P-PSMA-101
Description
Rate of dose limiting toxicities (DLT)
Time Frame
Baseline through Day 28
Title
Assess the efficacy of P-PSMA-101 (ORR)
Description
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).
Time Frame
Baseline through 15 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh Belani, M.D.
Organizational Affiliation
Sponsor Executive Medical Director
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Sarah Cannon Research Institute at HealthONE
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Tulane University Hospital and Clinic
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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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