P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Running, not enrolling · Phase 1
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT05239143
- Run by
- Poseida Therapeutics, Inc.
- People needed
- 180
- Starts
- 2022-02-15
- Expected to finish
- 2039-04-01
- Last updated by the study team
- 2026-02-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of California, Irvine Medical Center — Irvine, California, United States
- Cedars Sinai Medical Center — Los Angeles, California, United States
- University of California, San Diego — San Diego, California, United States
- University of California, San Francisco — San Francisco, California, United States
- Sarah Cannon Research Institute at HealthONE — Denver, Colorado, United States
- University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
- University of Kansas Cancer Center — Westwood, Kansas, United States
- Cancer Center of Kansas — Wichita, Kansas, United States
- University of Maryland Cancer Center — Baltimore, Maryland, United States
- Dana Farber Cancer Institute — Boston, Massachusetts, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Montefiore Medical Center — The Bronx, New York, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- NEXT Oncology — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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