Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion

Description

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.

Official Title

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

Details

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.

Keywords

Breast Cancer Ovarian Cancer Non Small Cell Lung Cancer Colorectal Cancer Pancreatic Cancer Renal Cell Carcinoma Nasopharyngeal Cancer Head and Neck Squamous Cell Carcinoma Gastric Cancer Carcinoma Carcinoma, Renal Cell Squamous Cell Carcinoma of Head and Neck Nasopharyngeal Neoplasms Nasopharyngeal Carcinoma P-MUC1C-ALLO1 CAR-T cells Rimiducid

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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, refractory to standard of care therapy or ineligible or refused other existing treatment options
  • Must have progressed during or after last therapy 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 CAN'T join if...

  • Has inadequate venous access
  • Has an active second malignancy 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 conditioning chemotherapy
  • 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

Locations

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States
  • Sarah Cannon Research Institute at HealthONE accepting new patients
    Denver Colorado 80218 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Poseida Therapeutics, Inc.
ID
NCT05239143
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated