Actively Recruiting
Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas
Led by Essen Biotech · Updated on 2025-07-15
60
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, non-randomized, multicenter Phase 1/2 trial evaluating a dual CAR-T cell therapy targeting CD146 and HER2 in patients with advanced sarcoma. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by sequential infusion of autologous CD146-specific and HER2-specific CAR-T cells. The Phase 1 portion will employ a dose-escalation design to assess safety and determine the recommended Phase 2 dose, while the Phase 2 expansion will evaluate preliminary efficacy (tumor response and survival outcomes). Approximately 40 patients (children and adults) with relapsed or refractory sarcomas will be enrolled across multiple centers. All participants will be followed for up to 36 months to monitor dose-limiting toxicities, objective response rates, progression-free survival, overall survival, and long-term safety.
CONDITIONS
Official Title
Sequential Infusion of CD146-Targeted and HER2-Targeted CAR T Cells in Patients With Advanced Sarcomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Expected survival of 3 months or more
- Histologically or cytologically confirmed metastatic, locally advanced, or refractory soft tissue or bone sarcoma
- Evidence of measurable disease according to RECIST or applicable criteria
- Prior treatment with at least one systemic therapy for sarcoma or no standard therapy available for subtype
- Minimum 2-week washout from prior chemotherapy, radiation, or immunotherapy before lymphodepletion
- Age 12 years or older with upper age limit around 75 years or medically fit
- ECOG performance status 0-1 or Karnofsky score 70% or higher for pediatric patients
- Adequate organ function including cardiac ejection fraction ≥50%, oxygen saturation >92% on room air, bone marrow reserves, liver and kidney function
- Tumor expression of CD146 and/or HER2 recommended when feasible
- Ability to understand and give informed consent or assent with guardian consent for minors
- Willingness to comply with study procedures and follow-up
You will not qualify if you...
- Prior treatment with CAR-T or other gene-modified T-cell therapy
- Receipt of investigational drug, immunotherapy, or major surgery within 4 weeks before enrollment
- Active uncontrolled infection including hepatitis B or C, HIV with uncontrolled viral load, or active tuberculosis
- Use of systemic immunosuppressive medications above physiologic replacement doses within 7 days before leukapheresis
- History of allogeneic stem cell or solid organ transplant
- Significant uncontrolled medical conditions such as active autoimmune disease requiring immunosuppression, severe heart failure, unstable angina or recent myocardial infarction, severe chronic respiratory disease requiring oxygen, or psychiatric conditions interfering with participation
- Pregnant or breastfeeding women
- Inability or unwillingness to use effective contraception during the study and for one year after CAR-T infusion
- Concurrent enrollment in another interventional clinical trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
District One Hospital
Beijing, Beijing Municipality, China, 086-373
Actively Recruiting
Research Team
R
Rhoda M Smith, Phd
CONTACT
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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