Poseida, P-MUC1C-ALLO1-001, Ph1,Open,Advanced or Metastatic Solid Tumors,P-MUC1C-ALLO1 and rimiducid

What is the Purpose of this Study?

Primary: Part 1 To determine the MTD and/or RP2D of P-MUC1C-ALLO1 based on dose-limiting toxicities (DLTs). To evaluate the overall safety and tolerability profile of PMUC1C-ALLO1 Part 2 To confirm the safety and tolerability of the RP2D. To further evaluate the preliminary efficacy of PMUC1C-ALLO1. Secondary: Part 1/Part 2 The preliminary efficacy of PMUC1C-ALLO1. The effect of cell dose to guide selection of doses for further assessment in Phase 2/3 studies

Eligibility

* 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%

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

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Where can I participate?

CS Cancer at Cedars-Sinai Medical Center : Shannon Cyhan, Saba Mukarram
CS Cancer at The Angeles Clinic and Research Institute : Shannon Cyhan, Saba Mukarram

More about this Clinical Trial

What is the full name of this clinical trial?

P-MUC1C-ALLO1-001: A Phase 1 Dose Escalation and Expanded Cohort of P-MUC1C-ALLO1 in Adult Subjects with Advanced or Metastatic Solid Tumors

Study Details

Disease Type/Condition

Breast, Kidney, Larynx, Lip, Oral Cavity and Pharynx, Lung, Other Female Genital, Pancreas, Stomach

Principal Investigator

Moyers, Justin

Co-Investigators

Akil Merchant, Andrew Hendifar, Cathie T Chung, David Oveisi, Hannah Lee, Inderjit Mehmi, Iryna Singh, John Chute, Joshua Sasine, Jun Gong, Justin Darrah, Kristopher Wentzel, Navid Hafez, Noah Merin, Omid Hamid, Robert Vescio, Ronald Paquette, Vi K. Chiu, Yuan Yuan

Age Group

Adult

Phase

IRB Number

STUDY00002368

ClinicalTrials.gov ID

NCT05239143

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org