A Phase I Interventional Open-label, Non-randomized Dose-escalation Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Anti-tumor Activity of Autologous p95HER2.CAR-TECH2Me T Cells in Patients With Selected Advanced Cancers.

This is a phase I, open-label, non-randomized, multicenter, dose-escalation trial designed to evaluate the safety, tolerability, and preliminary anti-tumor activity of autologous p95HER2.CAR-TECH2Me T cells in patients with selected advanced HER2-positive (3+) cancers, including locally advanced, recurrent, or metastatic breast, gastric, endometrial, and other selected solid tumors. The study will also assess pharmacokinetics, pharmacodynamics, and immunogenicity of p95HER2.CAR-TECH2Me following intravenous administration. Treatment consists of non-myeloablative lymphodepletion chemotherapy w

Trial Details

NCT ID
NCT07593820
Phase
PHASE1
Sponsor
Vall d'Hebron Institute of Oncology
Status
RECRUITING
Cancer Type
Breast Cancer
Interventions
  • p95HER2.CAR-TECH2Me
Locations (sample)
  • Barcelona, Catalonia, Spain|41.38879,2.15899
  • Barcelona, Catalonia, Spain|41.38879,2.15899

Key Eligibility Criteria

  • Patients must understand and voluntarily sign an informed consent document before any study-related assessments/procedures being conducted.
  • Age ≥ 18 and years at the time of signing the ICF
  • Patients must be able and willing to comply with the study visit schedule and protocol requirements.
  • Patients must have a clinical performance of Eastern Cooperative Oncology Group 0 or 1.

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Breast Cancer Trials on Trialify →