P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
NCT ID: NCT05239143
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
180 participants
INTERVENTIONAL
2022-02-15
2039-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
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.
P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
Interventions
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P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Poseida Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Simon Heidegger, M.D.
Role: STUDY_DIRECTOR
Lead Medical Director, Oncology, Genentech Research Early Development
Locations
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University of California, Irvine Medical Center
Irvine, California, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Kansas Cancer Center
Westwood, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
University of Maryland Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Montefiore Medical Center
The Bronx, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
Countries
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References
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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.
Other Identifiers
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P-MUC1C-ALLO1-001
Identifier Type: -
Identifier Source: org_study_id