P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Purpose
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.
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
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Intervention Model Description
- Open label, 3 + 3 design of dose-escalating cohorts with open label, dose expansion at recommended phase 2 dose (RP2D)
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A) |
- Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. - Rimiducid may be administered as indicated. |
|
|
Experimental P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm B) |
- Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. - Rimiducid may be administered as indicated. |
|
|
Experimental P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm C) |
- Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 2. - Rimiducid may be administered as indicated. |
|
|
Experimental P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm D) |
- Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 2. - Rimiducid may be administered as indicated. |
|
|
Experimental P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm A1) |
- Single ascending A1 dose cohorts, given in a single intravenous infusion of CAR-T cells, following lymphodepletion regimen 1. - Rimiducid may be administered as indicated. |
|
|
Experimental P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm E) |
- Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. - Rimiducid may be administered as indicated. |
|
|
Experimental P-MUC1C-ALLO1 CAR-T cells (Multiple Dose - Arm F) |
- Cyclic administration of ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. - Rimiducid may be administered as indicated. |
|
|
Experimental P-MUC1C-ALLO1 CAR-T cells (Single Dose - Arm M) |
- Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells, following assigned lymphodepletion regimen. - Rimiducid may be administered as indicated. |
|
Recruiting Locations
University of Kansas Cancer Center
Westwood, Kansas 66205
Westwood, Kansas 66205
More Details
- Status
- Recruiting
- Sponsor
- Poseida Therapeutics, Inc.
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.