Breast Cancer Clinical Trial
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.
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.
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
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
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There are 9 Locations for this study
Los Angeles California, 90048, United States
San Diego California, 92037, United States
San Francisco California, 94143, United States
Denver Colorado, 80218, United States
Westwood Kansas, 66205, United States
Wichita Kansas, 67214, United States
Bronx New York, 10467, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
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