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Clinical Trials in the USA / NCT05239143
Active, not recruiting Phase 1

P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors

NCT05239143 · tracked via the Priya Life Science USA tracker
Sponsor
Poseida Therapeutics, Inc.
Phase
Phase 1
Started
2022-02-15
Last updated
2026-02-09

Condition(s) studied

Breast CancerOvarian CancerNon Small Cell Lung CancerColorectal CancerPancreatic CancerRenal Cell CarcinomaNasopharyngeal CancerHead and Neck Squamous Cell CarcinomaGastric Cancer

Investigational drug(s) / intervention(s)

P-MUC1C-ALLO1 CAR-T cellsRimiducid

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (14)

FacilityCityRegionStatus
University of California, Irvine Medical Center Irvine California
Cedars Sinai Medical Center Los Angeles California
University of California, San Diego San Diego California
University of California, San Francisco San Francisco California
Sarah Cannon Research Institute at HealthONE Denver Colorado
University of Iowa Hospitals and Clinics Iowa City Iowa
University of Kansas Cancer Center Westwood Kansas
Cancer Center of Kansas Wichita Kansas
University of Maryland Cancer Center Baltimore Maryland
Dana Farber Cancer Institute Boston Massachusetts
University of Nebraska Medical Center Omaha Nebraska
Montefiore Medical Center The Bronx New York
MD Anderson Cancer Center Houston Texas
NEXT Oncology San Antonio Texas

More Poseida Therapeutics, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05239143 on ClinicalTrials.gov ↗ ← All trials in the USA