P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer, Non Small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Breast Cancer
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, 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
Exclusion Criteria:
- 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
Sites / Locations
- Cedars Sinai Medical Center
- University of California, San DiegoRecruiting
- University of California, San FranciscoRecruiting
- Sarah Cannon Research Institute at HealthONERecruiting
- University of Kansas Cancer CenterRecruiting
- Cancer Center of KansasRecruiting
- Montefiore Medical CenterRecruiting
- MD Anderson Cancer CenterRecruiting
- NEXT OncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A)
P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B)
P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C)
P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D)
Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 1. Rimiducid may be administered as indicated.
Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 1. Rimiducid may be administered as indicated.
Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 2. Rimiducid may be administered as indicated.
Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following conditioning chemotherapy regimen 2. Rimiducid may be administered as indicated.