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

Breast Cancer Clinical Trial

Official title:

A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05239143
• Other study ID #: P-MUC1C-ALLO1-001
• Status: Recruiting
• Phase: Phase 1
• Start date: February 15, 2022
• Est. completion date: April 2039

Study information

• Verified date: April 2024
• Source: Poseida Therapeutics, Inc.
• Contact: Angie Schinkel
• Phone: 858-779-3103
• Email: clinicaltrials[@]poseida.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2039
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma
• Carcinoma, Renal Cell
• Colorectal Cancer
• Gastric Cancer
• Head and Neck Squamous Cell Carcinoma
• Nasopharyngeal Cancer
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms
• Non Small Cell Lung Cancer
• Ovarian Cancer
• Pancreatic Cancer
• Renal Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Biological:
• P-MUC1C-ALLO1 CAR-T cells
P-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.

Drug:
• Rimiducid
Rimiducid (safety switch activator) may be administered as indicated.

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Sarah Cannon Research Institute at HealthONE	Denver	Colorado
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Froedtert Hospital and the Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	NEXT Oncology	San Antonio	Texas
United States	University of California, San Diego	San Diego	California
United States	University of California, San Francisco	San Francisco	California
United States	University of Kansas Cancer Center	Westwood	Kansas
United States	Cancer Center of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Poseida Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Baseline through Day 28
Primary	Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1	Frequency and severity of adverse events	Baseline through 15 years
Primary	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)	Baseline through 15 years