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.
Brief Title
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Breast Cancer
Ovarian Cancer
Non Small Cell Lung Cancer
Colorectal Cancer
Pancreatic Cancer
Renal Cell Carcinoma
Nasopharyngeal Cancer
Head and Neck Squamous Cell Carcinoma
Gastric 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
* 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
Exclusion Criteria:
* 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
* 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
Exclusion Criteria:
* 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
Inclusion 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
* 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT05239143
Org Class
Industry
Org Full Name
Poseida Therapeutics, Inc.
Org Study Id
P-MUC1C-ALLO1-001
Overall Status
Active, not recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors
Primary Outcomes
Outcome Description
Number of subjects with a dose limiting toxicity (DLT)
Outcome Measure
Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1
Outcome Time Frame
Baseline through Day 28
Outcome Description
Frequency and severity of adverse events
Outcome Measure
Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1
Outcome Time Frame
Baseline through 15 years
Outcome Description
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)
Outcome Measure
Evaluate the preliminary efficacy of P-MUC1C-ALLO1
Outcome Time Frame
Baseline through 15 years
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Roberto Alejandro Sica
Investigator Email
asica@montefiore.org