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NCT Number: NCT05239143

P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Adenocarcinoma Adnexal Diseases Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Carcinoma, Squamous Cell Colonic Diseases Colorectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Nasopharyngeal Cancer Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Non Small Cell Lung Cancer Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Pancreatic Cancer Pancreatic Diseases Pancreatic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Rectal Diseases Renal Cell Carcinoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Stomach Diseases Stomach Neoplasms Stomatognathic Diseases Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, Irvine Medical Center, Irvine, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

P-MUC1C-ALLO1 CAR-T cells

Biological

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

rimiducid

Drug

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

Primary outcomes

  1. Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1

    Time frame: 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

    Time frame: Baseline through 15 years

    Frequency and severity of adverse events

  3. Evaluate the preliminary efficacy of P-MUC1C-ALLO1

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Poseida Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors

Important dates

Study start
2022
Primary completion
2026
Study completion
2039
First posted
Feb 14, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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