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P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors

Primary Purpose

Breast Cancer, Ovarian Cancer, Non Small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
P-MUC1C-ALLO1 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 Breast Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Males or females, Subjects ≥18 years with life expectancy >3 months
  • Must have a confirmed diagnosis of unresectable, locally advanced or metastatic epithelial-derived cancer, refractory to standard of care therapy or ineligible or refused other existing treatment options
  • Must have progressed during or after last therapy and have measurable disease
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or Karnofsky performance status ≥70%
  • Must have adequate vital organ function within pre-determined parameters
  • Must have archived tumor tissue available or consent to a biopsy collection
  • Must be willing to practice birth control
  • Must have a negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration
  • Must have recovered from toxicities due to prior therapies

Exclusion Criteria:

  • Has inadequate venous access
  • Has an active second malignancy in addition to the studied malignancy, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma
  • Is pregnant or lactating
  • Has a history of or active autoimmune disease
  • Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy
  • Has an active systemic (viral, bacterial, or fungal) infection
  • Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia
  • Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol
  • Has received anticancer medications within 2 weeks of the time of initiating conditioning chemotherapy
  • Has received immunosuppressive medications within 2 weeks of administration of P-MUC1C-ALLO1, and/or expected to require them while enrolled in the study
  • Has received systemic corticosteroid therapy within 1 week of the administration of P-MUC1C-ALLO1 or is expected to require it during the course of the study
  • Has known CNS metastases or symptomatic CNS involvement
  • Has a history of significant liver disease or active liver disease
  • Has a history of known genetic predisposition to HLH/MAS

Sites / Locations

  • Cedars Sinai Medical Center
  • University of California, San DiegoRecruiting
  • University of California, San FranciscoRecruiting
  • Sarah Cannon Research Institute at HealthONERecruiting
  • University of Kansas Cancer CenterRecruiting
  • Cancer Center of KansasRecruiting
  • Montefiore Medical CenterRecruiting
  • MD Anderson Cancer CenterRecruiting
  • NEXT OncologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A)

P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B)

P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C)

P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D)

Arm Description

Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 1. 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 1. Rimiducid may be administered as indicated.

Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 2. 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 2. Rimiducid may be administered as indicated.

Outcomes

Primary Outcome Measures

Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1
Number of subjects with a dose limiting toxicity (DLT)
Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1
Frequency and severity of adverse events
Evaluate the preliminary efficacy of P-MUC1C-ALLO1
According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST): Overall Response Rate (ORR)

Secondary Outcome Measures

Full Information

First Posted
February 3, 2022
Last Updated
October 13, 2023
Sponsor
Poseida Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05239143
Brief Title
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Official Title
A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
April 2026 (Anticipated)
Study Completion Date
April 2039 (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

5. Study Description

Brief Summary
A Phase 1, open label, dose escalation and expanded cohort study of P-MUC1C-ALLO1 in adult subjects with advanced or metastatic epithelial derived solid tumors, including but not limited to the tumor types listed below.
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-MUC1C-ALLO1 to determine a Recommended Phase 2 Dose (RP2D). P-MUC1C-ALLO1 is an allogeneic chimeric antigen receptor (CAR) T cell therapy designed to target cancer cells expressing Mucin1 cell surface associated C-Terminal (MUC1-C) antigen. Additional participants will be treated with P-MUC1C-ALLO1 at the determined RP2D. Following enrollment, subjects will be treated with P-MUC1C-ALLO1 and will undergo serial measurements of safety, tolerability and response. 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
Breast Cancer, Ovarian Cancer, Non Small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Renal Cell Carcinoma, Nasopharyngeal Cancer, Head and Neck Squamous Cell Carcinoma, Gastric Cancer

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 recommended phase 2 dose (RP2D)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A)
Arm Type
Experimental
Arm Description
Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 1. Rimiducid may be administered as indicated.
Arm Title
P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B)
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 1. Rimiducid may be administered as indicated.
Arm Title
P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C)
Arm Type
Experimental
Arm Description
Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 2. Rimiducid may be administered as indicated.
Arm Title
P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D)
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 2. Rimiducid may be administered as indicated.
Intervention Type
Biological
Intervention Name(s)
P-MUC1C-ALLO1 CAR-T cells
Intervention Description
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Intervention Type
Drug
Intervention Name(s)
Rimiducid
Intervention Description
Rimiducid (safety switch activator) may be administered as indicated.
Primary Outcome Measure Information:
Title
Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1
Description
Number of subjects with a dose limiting toxicity (DLT)
Time Frame
Baseline through Day 28
Title
Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1
Description
Frequency and severity of adverse events
Time Frame
Baseline through 15 years
Title
Evaluate the preliminary efficacy of P-MUC1C-ALLO1
Description
According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST): Overall Response Rate (ORR)
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: Males or females, Subjects ≥18 years with life expectancy >3 months Must have a confirmed diagnosis of unresectable, locally advanced or metastatic epithelial-derived cancer, refractory to standard of care therapy or ineligible or refused other existing treatment options Must have progressed during or after last therapy and have measurable disease Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 or Karnofsky performance status ≥70% Must have adequate vital organ function within pre-determined parameters Must have archived tumor tissue available or consent to a biopsy collection Must be willing to practice birth control Must have a negative pregnancy test at screening and prior to initiating lymphodepletion chemotherapy or study drug administration Must have recovered from toxicities due to prior therapies Exclusion Criteria: Has inadequate venous access Has an active second malignancy in addition to the studied malignancy, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma Is pregnant or lactating Has a history of or active autoimmune disease Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy Has an active systemic (viral, bacterial, or fungal) infection Has New York Heart Association (NYHA) Class III or IV heart failure, unstable angina, or a history of myocardial infarction or significant arrhythmia Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol Has received anticancer medications within 2 weeks of the time of initiating conditioning chemotherapy Has received immunosuppressive medications within 2 weeks of administration of P-MUC1C-ALLO1, and/or expected to require them while enrolled in the study Has received systemic corticosteroid therapy within 1 week of the administration of P-MUC1C-ALLO1 or is expected to require it during the course of the study Has known CNS metastases or symptomatic CNS involvement Has a history of significant liver disease or active liver disease Has a history of known genetic predisposition to HLH/MAS
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angie Schinkel
Phone
858-779-3103
Email
clinicaltrials@poseida.com
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
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Sarah Cannon Research Institute at HealthONE
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Kansas Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Individual Site Status
Recruiting
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
NEXT Oncology
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors

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