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Active, not recruitingNCT05239143Updated Feb 9, 2026

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

A Phase 1 interventional study of P-MUC1C-ALLO1 CAR-T cells and Rimiducid in Breast Cancer, Ovarian Cancer and Non Small Cell Lung Cancer, sponsored by Poseida Therapeutics, Inc.. Active, not recruiting at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.

Sponsored by Poseida Therapeutics, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
  • Must have progressed during or after last therapy, developed intolerance/toxicity to current treatment, or ineligible or refused other existing treatment options, 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

Exclusion Criteria:

  • Has inadequate venous access
  • Has an active second malignancy (not disease free for at least 5 years) 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 lymphodepletion
  • 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
  • Has received anti-cancer monoclonal antibody therapy within 4 weeks of initiating LD therapy
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • 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 lymphodepletion regimen 1. * Rimiducid may be administered as indicated.

    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 lymphodepletion regimen 1. * Rimiducid may be administered as indicated.

    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 lymphodepletion regimen 2. * Rimiducid may be administered as indicated.

    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 lymphodepletion regimen 2. * Rimiducid may be administered as indicated.

    Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid

  • Experimental
    P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A1)

    * Single ascending A1 dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.

    Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid

  • Experimental
    P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm E)

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

    Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid

  • Experimental
    P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm F)

    * Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.

    Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid

  • Experimental
    P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm M)

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

    Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid

Interventions

  • BiologicalP-MUC1C-ALLO1 CAR-T cells

    P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.

  • DrugRimiducid

    Rimiducid (safety switch activator) may be administered as indicated.

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Baseline through Day 28

  2. Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1

    Frequency and severity of adverse events

    Time frame: Baseline through 15 years

  3. 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)

    Time frame: Baseline through 15 years

06

Study locations

14 sites
  • University of California, Irvine Medical Center
    Irvine, California 92868, United States
  • Cedars Sinai Medical Center
    Los Angeles, California 90048, United States
  • University of California, San Diego
    San Diego, California 92037, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • Sarah Cannon Research Institute at HealthONE
    Denver, Colorado 80218, United States
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
  • University of Kansas Cancer Center
    Westwood, Kansas 66205, United States
  • Cancer Center of Kansas
    Wichita, Kansas 67214, United States
  • University of Maryland Cancer Center
    Baltimore, Maryland 21201, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02215, United States
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198, United States
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
  • MD Anderson Cancer Center
    Houston, Texas 77030, United States
  • NEXT Oncology
    San Antonio, Texas 78229, United States
07

References and documents

Publications

  • Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025. PubMed 40443562 ↗
08

Registry details

Key details

Study ID
NCT05239143
Lead sponsor
Poseida Therapeutics, Inc.
Responsible party
Sponsor
First posted
Feb 14, 2022
Start date
Feb 15, 2022
Primary completion
Apr 2026 (estimated)
Completion
Apr 2039 (estimated)
Last update
Feb 9, 2026

Study contacts

Simon Heidegger, M.D.
study director · Lead Medical Director, Oncology, Genentech Research Early Development

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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