P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors
1 other identifier
interventional
180
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 breast-cancer
Started Feb 2022
Longer than P75 for phase_1 breast-cancer
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedStudy Start
First participant enrolled
February 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2039
ExpectedFebruary 9, 2026
February 1, 2026
4.1 years
February 3, 2022
February 6, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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)
Baseline through Day 28
Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1
Frequency and severity of adverse events
Baseline through 15 years
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)
Baseline through 15 years
Study Arms (8)
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid (safety switch activator) may be administered as indicated.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
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
Related Publications (1)
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.
PMID: 40443562DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Simon Heidegger, M.D.
Lead Medical Director, Oncology, Genentech Research Early Development
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2022
First Posted
February 14, 2022
Study Start
February 15, 2022
Primary Completion
April 1, 2026
Study Completion (Estimated)
April 1, 2039
Last Updated
February 9, 2026
Record last verified: 2026-02