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

February 6, 2026 updated by: Poseida Therapeutics, Inc.

A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
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.
Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
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.
Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
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.
Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
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.
Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
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.
Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
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.
Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
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.
Drug: Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline through Day 28
Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1
Time Frame: Baseline through 15 years
Frequency and severity of adverse events
Baseline through 15 years
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)
Baseline through 15 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poseida Therapeutics, Inc.

Investigators

  • Study Director: Simon Heidegger, M.D., Lead Medical Director, Oncology, Genentech Research Early Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2039

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-MUC1C-ALLO1-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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