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Active Not RecruitingNCT05239143

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

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

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
180 (estimated)
Sponsor
Poseida Therapeutics, Inc. · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALP-MUC1C-ALLO1 CAR-T cellsP-MUC1C-ALLO1 is an allogeneic CAR-T cell therapy designed to target cancer cells expressing MUC1-C.
DRUGRimiducidRimiducid (safety switch activator) may be administered as indicated.

Timeline

Start date
2022-02-15
Primary completion
2026-04-01
Completion
2039-04-01
First posted
2022-02-14
Last updated
2026-02-09

Locations

14 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT05239143. Inclusion in this directory is not an endorsement.