A Phase 1 interventional study of P-MUC1C-ALLO1 CAR-T cells and Rimiducid in Breast Cancer, Ovarian Cancer and Non Small Cell Lung Cancer, sponsored by Poseida Therapeutics, Inc.. Active, not recruiting at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by Poseida Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
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.
Exclusion Criteria:
* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. * Rimiducid may be administered as indicated.
Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid
* 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.
Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid
* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 2. * Rimiducid may be administered as indicated.
Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid
* 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.
Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid
* 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.
Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid
* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.
Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid
* 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.
Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid
* Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. * Rimiducid may be administered as indicated.
Biological: P-MUC1C-ALLO1 CAR-T cells · Drug: Rimiducid
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.
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)
Time frame: Baseline through Day 28
Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1
Frequency and severity of adverse events
Time frame: 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)
Time frame: Baseline through 15 years
This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Poseida Therapeutics, Inc.