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

• Status: Not yet recruiting
• Trial end date: 2039-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Poseida Therapeutics, Inc.

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, 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