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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
Rimiducid (safety switch activator) may be administered as indicated.
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
...and 4 more locations
Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1
Number of subjects with a dose limiting toxicity (DLT)
Time frame: Baseline through Day 28
Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1
Frequency and severity of adverse events
Time frame: Baseline through 15 years
Evaluate the preliminary efficacy of P-MUC1C-ALLO1
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)
Time frame: Baseline through 15 years
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