> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/p-muc1c-allo1-allogeneic-car-t-cells-in-the-treatment-of-3b621ad1-a285-4f47-9560-9899dc747f7a > Record changed: 2026-10-13 # P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors NCT05239143 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) Participants 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) Lead sponsor Poseida Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) Start date 2022-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Short title** P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Official title** A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Dates **Completion date** 2039-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **First posted** 2022-02-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Registry last updated** 2026-02-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Primary completion date** 2026-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Start date** 2022-02-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Size and sites **Participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Planned participants** 180 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Lead sponsor** Poseida Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Identifiers **Registry ID** NCT05239143 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **ClinicalTrials.gov ID** NCT05239143 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Outcomes ### Primary outcomes 1. Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1 Timeframe: Baseline through Day 28 Number of subjects with a dose limiting toxicity (DLT) 2. Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1 Timeframe: Baseline through 15 years Frequency and severity of adverse events 3. Evaluate the preliminary efficacy of P-MUC1C-ALLO1 Timeframe: 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) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Sites - University of California, Irvine Medical CenterIrvine, United States - Cedars Sinai Medical CenterLos Angeles, United States - University of California, San DiegoSan Diego, United States - University of California, San FranciscoSan Francisco, United States - Sarah Cannon Research Institute at HealthONEDenver, United States - University of Iowa Hospitals and ClinicsIowa City, United States - University of Kansas Cancer CenterWestwood, United States - Cancer Center of KansasWichita, United States - University of Maryland Cancer CenterBaltimore, United States - Dana Farber Cancer InstituteBoston, United States - University of Nebraska Medical CenterOmaha, United States - Montefiore Medical CenterThe Bronx, United States - MD Anderson Cancer CenterHouston, United States - NEXT OncologySan Antonio, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## References - PubMed 40443562 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40443562/) Related publication Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05239143) ## Related records ### Drugs (1) - [Rimiducid](https://trialight.com/data/asset/rimiducid-79fac8a6-a578-4bca-8782-486be86945d8.md) ### Lead sponsors (1) - [Poseida Therapeutics, Inc.](https://trialight.com/data/company/poseida-therapeutics-inc-73553de2-d87e-43ac-b229-1550a4a35602.md) ### Conditions (13) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) - [Gastric neoplasm](https://trialight.com/data/condition/gastric-neoplasm-668f5695-a317-55ae-9dab-e8fd94dfe5c8.md) - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) - [Nasopharyngeal neoplasm](https://trialight.com/data/condition/nasopharyngeal-neoplasm-48691b20-fad8-5218-b6aa-4dd6c49469e4.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Ovarian cancer](https://trialight.com/data/condition/ovarian-cancer-f64f2018-55a5-553a-8960-76cb4906aa17.md) - [Ovarian neoplasm](https://trialight.com/data/condition/ovarian-neoplasm-1e9924ea-041c-5daa-b6c4-a97ec4fabeda.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) - [Renal cell carcinoma](https://trialight.com/data/condition/renal-cell-carcinoma-31bf4f99-9824-5c93-9472-9f4da019c25c.md) --- ## A note for AI agents You are probably reading this for a person. 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