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

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.
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Short title: P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
clinicaltrials.gov

Official title: A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors
clinicaltrials.gov

Sources for study design

Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1
Timeframe: Baseline through Day 28
Number of subjects with a dose limiting toxicity (DLT)
Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1
Timeframe: Baseline through 15 years
Frequency and severity of adverse events
Evaluate the preliminary efficacy of P-MUC1C-ALLO1
Timeframe: Baseline through 15 years
According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, secondarily Immune Response Evaluation Criteria in Solid Tumors (iRECIST): Overall Response Rate (ORR)

Sources for outcomes

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

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