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

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ClinicalTrials.gov Identifier: NCT05239143
Recruitment Status : Recruiting
First Posted : February 14, 2022
Last Update Posted : April 23, 2024
Sponsor:
Information provided by (Responsible Party):
Poseida Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE February 3, 2022
First Posted Date  ICMJE February 14, 2022
Last Update Posted Date April 23, 2024
Actual Study Start Date  ICMJE February 15, 2022
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2022)
  • Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1 [ Time Frame: Baseline through Day 28 ]
    Number of subjects with a dose limiting toxicity (DLT)
  • Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1 [ Time Frame: Baseline through 15 years ]
    Frequency and severity of adverse events
  • Evaluate the preliminary efficacy of P-MUC1C-ALLO1 [ 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): Overall Response Rate (ORR)
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-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Official Title  ICMJE A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors
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.
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 recommended phase 2 dose (RP2D)
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • Biological: P-MUC1C-ALLO1 CAR-T cells
    P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
  • Drug: Rimiducid
    Rimiducid (safety switch activator) may be administered as indicated.
Study Arms  ICMJE
  • Experimental: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A)
    • 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.
    Interventions:
    • Biological: P-MUC1C-ALLO1 CAR-T cells
    • Drug: Rimiducid
  • Experimental: P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B)
    • 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.
    Interventions:
    • Biological: P-MUC1C-ALLO1 CAR-T cells
    • Drug: Rimiducid
  • Experimental: P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C)
    • 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.
    Interventions:
    • Biological: P-MUC1C-ALLO1 CAR-T cells
    • Drug: Rimiducid
  • Experimental: P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D)
    • 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.
    Interventions:
    • Biological: P-MUC1C-ALLO1 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: February 3, 2022)		 100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2039
Estimated Primary Completion Date April 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT05239143
Other Study ID Numbers  ICMJE P-MUC1C-ALLO1-001
Has Data Monitoring Committee Not Provided
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 Not Provided
Current Responsible Party Poseida Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Poseida Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rajesh Belani, M.D. Sponsor Executive Medical Director
PRS Account Poseida Therapeutics, Inc.
Verification Date April 2024

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