Condition: Metastatic Gastric Cancer · Metastatic Breast Cancer · Endometrial Cancer Metastatic · Sponsor: Vall d'Hebron Institute of Oncology
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 with cyclophosphamide and fludarabine administered on Days -4 to -2, followed by a single infusion of p95HER2.CAR-TECH2Me cells on Day 0. The investigational product is a live cell suspension of autologous CAR-T lymphocytes derived from the patient's peripheral blood. Premedication will be administered before cell infusion according to protocol requirements. The primary objective of the study is to evaluate the safety and tolerability of p95HER2.CAR-TECH2Me and to identify the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D). Primary endpoints include the nature and frequency of adverse events, serious adverse events, clinically relevant changes in laboratory parameters, electrocardiograms, vital signs, physical examination findings, and ECOG performance status, as well as the incidence and nature of dose-limiting toxicities. Adverse events will be graded according to NC…
This description comes directly from the study's public registry record.
Irene Braña, Dr · +932746085 · ibrana@vhio.net
Always discuss trial participation with your own doctor first.
| Hospital Del Mar | Barcelona, Catalonia, Spain | Not Yet Recruiting |
| Hospital Universitari Vall D Hebron | Barcelona, Catalonia, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07593820