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Breast CancerPhase 1NCT05239143

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

A Phase 1 study testing P-MUC1C-ALLO1 CAR-T cells and Rimiducid in people with Breast Cancer and Ovarian Cancer, run by Poseida Therapeutics, Inc. at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
What is being tested?
P-MUC1C-ALLO1 CAR-T cells and Rimiducid
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
14 sitesUnited States
Study dates
15 Feb 2022to Apr 2039
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites
  • University of Maryland Cancer Center

    Baltimore, Maryland, 21201

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Sarah Cannon Research Institute at HealthONE

    Denver, Colorado, 80218

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of California, Irvine Medical Center

    Irvine, California, 92868

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • NEXT Oncology

    San Antonio, Texas, 78229

  • University of California, San Diego

    San Diego, California, 92037

  • University of California, San Francisco

    San Francisco, California, 94143

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: 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.

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.

Being tested
P-MUC1C-ALLO1 CAR-T cells, Rimiducid
Medical subject headings
Breast Neoplasms, Ovarian Neoplasms, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Pancreatic Neoplasms, Carcinoma, Renal Cell, Nasopharyngeal Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • P-MUC1C-ALLO1 CAR-T cellsBiological

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

  • RimiducidDrug

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

Study groups in NCT05239143
Study groupRoleWhat they receive
P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A)Experimental* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.
Receives: Biological: P-MUC1C-ALLO1 CAR-T cells; Drug: Rimiducid
P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B)Experimental* 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.
Receives: Biological: P-MUC1C-ALLO1 CAR-T cells; Drug: Rimiducid
P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C)Experimental* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 2. * Rimiducid may be administered as indicated.
Receives: Biological: P-MUC1C-ALLO1 CAR-T cells; Drug: Rimiducid
P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D)Experimental* 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.
Receives: Biological: P-MUC1C-ALLO1 CAR-T cells; Drug: Rimiducid
P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A1)Experimental* 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.
Receives: Biological: P-MUC1C-ALLO1 CAR-T cells; Drug: Rimiducid
P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm E)Experimental* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.
Receives: Biological: P-MUC1C-ALLO1 CAR-T cells; Drug: Rimiducid
P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm F)Experimental* 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.
Receives: Biological: P-MUC1C-ALLO1 CAR-T cells; Drug: Rimiducid
P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm M)Experimental* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.
Receives: Biological: P-MUC1C-ALLO1 CAR-T cells; Drug: Rimiducid

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline through Day 28

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

    Frequency and severity of adverse events

    Measured: 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)

    Measured: Baseline through 15 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start15 Feb 2022
  3. Primary completionApr 2039 (estimated)
  4. Study completionApr 2039 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
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)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05239143
Sponsor's protocol ID
P-MUC1C-ALLO1-001
Status last verified
Nov 2026
First submitted
3 Feb 2022
Last updated
5 Nov 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing P-MUC1C-ALLO1 CAR-T cells and Rimiducid in people with Breast Cancer and Ovarian Cancer, run by Poseida Therapeutics, Inc. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1 (time frame: Baseline through Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05239143, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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