Actively Recruiting
A Phase I Open-label, Non-randomized Dose-escalation Trial Evaluating Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of Autologous p95HER2.CAR-TECH2Me T Cells in Patients with Selected Advanced HER2-positive Cancers
Led by Vall d'Hebron Institute of Oncology · Updated on 2026-05-22
15
Participants Needed
2
Research Sites
565 weeks
Total Duration
On this page
Sponsors
V
Vall d'Hebron Institute of Oncology
Lead Sponsor
B
Banc de Sang i Teixits
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the safety, tolerability, and early anti-tumor effects of autologous p95HER2.CAR-TECH2Me T cells in adults with advanced HER2-positive cancers, including breast, gastric, endometrial, and other selected solid tumors. This phase I, open-label, non-randomized, dose-escalation trial also evaluates how the body processes and responds to these cells after intravenous administration. Participants will receive a non-myeloablative lymphodepleting chemotherapy regimen with cyclophosphamide and fludarabine on Days -4 to -2, followed by a single infusion of the p95HER2.CAR-TECH2Me cells on Day 0. Premedication is given before the cell infusion to prepare patients. The dosing of the investigational CAR-T cells varies based on the dose-escalation group assigned. Throughout the study, participants will be closely monitored for adverse events, laboratory abnormalities, vital signs, ECG changes, physical examination findings, and performance status up to three months post-infusion. Researchers will assess tumor response, progression-free survival, and overall survival for up to two years after treatment. The total study duration is approximately 60 months, including follow-up contacts from initial consent to final evaluation.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older who voluntarily sign informed consent
- Ability and willingness to comply with study visits and protocol requirements
- Eastern Cooperative Oncology Group performance status of 0 or 1
- Life expectancy of at least 12 weeks
- Histologically or cytologically confirmed unresectable or metastatic tumors refractory to standard therapy or with no standard therapy available
- HER2-positive tumors with a 3+ intensity score by certified laboratory testing
- Measurable disease by RECIST v1.1 criteria
- Adequate hematological, renal, and hepatic function as defined by specific laboratory values
- Seronegative for HIV, active hepatitis B and C, and other specified infections
- Left ventricular ejection fraction of 50% or higher
- Pulmonary function test results of 50% or higher for FEV1, FVC, and DLCO
- Agreement to use effective contraception during the study and for specified periods after treatment
- Female participants must not be pregnant or breastfeeding and meet contraception or abstinence criteria
- Male participants must agree to contraception or abstinence and not donate sperm during and after treatment
- Adequate expansion of p95HER2.CAR-TECH2Me cells before chemotherapy
- Recovery to grade 1 or less of any prior systemic therapy toxicities at least 4 weeks before enrollment
- Recovery to grade 1 or less from minor surgical procedures within the past 3 weeks
You will not qualify if you...
- Symptomatic or untreated brain metastases; treated brain metastases considered only if stable and asymptomatic
- Leptomeningeal carcinomatosis
- Active or recent invasive malignancy within 3 years, with some exceptions
- Active systemic infection requiring treatment within 14 days before chemotherapy
- Active hepatitis B or C infections
- Active autoimmune disease needing immunosuppressive treatment
- History of organ or bone marrow transplantation
- Primary immunodeficiency disorders
- Regular steroid treatment (except certain permitted uses)
- Uncontrolled or progressive significant organ diseases within 6 months
- History of coronary revascularization or ischemic symptoms
- Idiopathic pulmonary fibrosis or active pneumonitis
- Allergies to treatment compounds
- Contraindications to cyclophosphamide or fludarabine
- Recent anti-cancer treatments within 4 weeks before chemotherapy with some exceptions
- Recent investigational agents or live attenuated vaccinations within 4 weeks
- Major surgery within 3 weeks before chemotherapy
- Prior investigational cell or gene therapies
- Pregnant or breastfeeding women of childbearing potential
- Conditions that may hinder compliance with the study protocol
- Other severe medical conditions increasing study risk as assessed by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants receive non-myeloablative lymphodepleting chemotherapy for 3 days followed by a single infusion of autologous p95HER2.CAR-TECH2Me cells.
1 to 4 visits including chemotherapy days and infusion day
Duration - Up to 2 years
Participants are monitored for safety, adverse events, and treatment response for up to 3 months after infusion, with additional assessments for up to 2 years.
Regular visits for safety and efficacy assessments during follow-up
Trial Site Locations
Total: 2 locations
1
Hospital Del Mar
Barcelona, Catalonia, Spain, 08003
Not Yet Recruiting
2
Hospital Universitari Vall D Hebron
Barcelona, Catalonia, Spain, 08035
Actively Recruiting
Research Team
I
Irene Braña, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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