Spots Global Cancer Trial Database for P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
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Trial Identification
Brief Title: P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Official Title: A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors
Study ID: NCT05239143
Study Description
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.
Detailed Description: 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Dana Farber Cancer Institute, Boston, Massachusetts, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Montefiore Medical Center, Bronx, New York, United States
MD Anderson Cancer Center, Houston, Texas, United States
NEXT Oncology, San Antonio, Texas, United States
Froedtert Hospital and the Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Contact Details
Name: Rajesh Belani, M.D.
Affiliation: Sponsor Executive Medical Director
Role: STUDY_DIRECTOR
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