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.

Sponsor
Vall d'Hebron Institute of Oncology
Study ID
NCT07593820
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • p95HER2.CAR-TECH2Me — BIOLOGICAL
    The treatment includes NMA-LD chemotherapy (cyclophosphamide 500 mg/m²/day + fludarabine 30mg/m2/day for three days) and p95HER2.CAR-TECH2Me cell infusion (1 day). The p95HER2.CAR-TECH2Me product is a cellular investigational product comprising a live cell suspension of autologous CAR-T lymphocytes derived from the patient's peripheral blood.

Study Details

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 NCI CTCAE v5.0, with cytokine release syndrome and neurotoxicity graded according to established consensus criteria. Secondary objectives include evaluation of preliminary anti-tumor activity and survival outcomes. Secondary endpoints include objective response rate, duration of response, progression-free survival according to RECIST v1.1 as assessed by the investigator, and overall survival. Approximately 15 patients are planned for enrollment over an estimated 36 to 48 months. The total study duration is expected to be approximately 60 months from the time the first subject signs the pre-screening informed consent form until the last subject completes the final study-related follow-up contact.

Key Dates

First listed
May 18, 2026
Start date
Apr 29, 2026
Status verified
Dec 2025
Primary completion
Jun 1, 2030
Completion
Apr 1, 2041

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: p95HER2.CAR-TECH2Me following lymphodepleting chemotherapy
    Participants will receive non-myeloablative lymphodepleting chemotherapy consisting of cyclophosphamide 500 mg/m²/day intravenously and fludarabine 30 mg/m²/day intravenously on Days -4 to -2, followed by a single intravenous infusion of autologous p95HER2.CAR-TECH2Me cells on Day 0. Premedication will be administered prior to p95HER2.CAR-TECH2Me infusion according to protocol requirements. The dose of p95HER2.CAR-TECH2Me will vary by dose-escalation cohort.

Primary Outcome Measure

Number of participants with adverse events and serious adverse events graded according to CTCAE v5.0 [ Time Frame: Up to 3 months after the infusion ]

Central Contacts

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