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A Phase 1 Dose Escalation and Expanded Cohort Study of P-MUC1C-ALLO1 in Adult Subjects With Advanced or Metastatic Solid Tumors
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.
Details
| Lead sponsor | Poseida Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 180 |
| Start date | 2022-02-15 |
| Completion | 2039-04 |
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
Interventions
- P-MUC1C-ALLO1 CAR-T cells
- Rimiducid
Primary outcomes
- Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of P-MUC1C-ALLO1 — Baseline through Day 28
Number of subjects with a dose limiting toxicity (DLT) - Evaluate the overall safety and tolerability profile of P-MUC1C-ALLO1 — Baseline through 15 years
Frequency and severity of adverse events - Evaluate the preliminary efficacy of P-MUC1C-ALLO1 — Baseline through 15 years
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)
Countries
United States