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

Introduction

• Org Study ID: P-MUC1C-ALLO1-001
• NTC ID: NCT05239143
• Lead Sponsor Name: Poseida Therapeutics, Inc.
• Status: RECRUITING

Conditions

• Chromophobe Renal Cell Carcinoma
• Clear Cell Renal Cell Carcinoma
• Collecting Duct Renal Cell Carcinoma
• Papillary Renal Cell Carcinoma
• Renal Medullary Carcinoma
• Translocation/TFE Renal Cell Carcinoma
• Unclassified Renal Cell Carcinoma

Brief 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 Criteria

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