Actively Recruiting
A Phase 1/2 Open-Label, Multicenter Trial of 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
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new dual CAR-T cell therapy targeting CD146 and HER2 in patients with advanced sarcomas, including soft tissue and bone sarcomas that have come back or do not respond to standard treatments. This open-label, non-randomized Phase 1/2 trial aims to assess safety, determine appropriate dosing, and explore preliminary effectiveness in reducing tumor size and improving survival. The study is sponsored by Essen Biotech and includes children and adults with measurable disease who have had prior systemic therapy. Participants will first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide to prepare their bodies for CAR-T therapy. Then, they will be given sequential infusions of CD146-targeted and HER2-targeted CAR-T cells intravenously, initially on day 0, with possible additional doses for those responding well without severe side effects. The trial includes a Phase 1 dose-escalation portion to find the recommended dose and a Phase 2 expansion to further evaluate safety and early efficacy. Throughout the study, participants will be closely monitored for side effects such as cytokine release syndrome and neurotoxicity, with follow-up lasting up to 36 months to observe long-term safety and treatment response. Assessments include physical exams, lab tests, imaging scans every 8 to 12 weeks, and analysis of immune responses. Researchers will measure dose-limiting toxicities, tumor response rates, progression-free and overall survival, aiming to understand how well dual CAR-T therapy works and its safety profile in advanced sarcoma patients.
CONDITIONS
Brief 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 time of at least 3 months
- Histologically or cytologically confirmed metastatic, locally advanced, or refractory sarcoma, including osteosarcoma, Ewing sarcoma, rhabdomyosarcoma, leiomyosarcoma, or other high-grade sarcomas with measurable disease
- Progressed on or not candidates for standard first-line treatments; typically at least one prior systemic therapy for sarcoma
- Age 12 years and older; upper age limit about 75 years or medically fit
- ECOG performance status 0-1 or Karnofsky score 70% or higher for pediatric patients
- Adequate cardiac, respiratory, hepatic, renal, and bone marrow function
- Tumor expression of CD146 and/or HER2 recommended
- Ability to understand and provide informed consent or assent, with willingness to comply with study procedures and follow-up
You will not qualify if you...
- Prior treatment with any CAR-T or gene-modified T-cell therapy
- Receipt of investigational drugs, immunotherapy, or major surgery within about 4 weeks before enrollment
- Active uncontrolled infections including hepatitis B, hepatitis C, HIV with uncontrolled viral load, tuberculosis, or other severe infections
- Use of systemic immunosuppressive medications above physiologic doses within 7 days before leukapheresis
- History of allogeneic stem cell transplant or solid organ transplant
- Significant uncontrolled medical conditions such as active autoimmune diseases needing immunosuppression, severe heart failure, unstable angina, recent myocardial infarction, severe chronic respiratory disease requiring oxygen, or psychiatric disorders interfering with participation
- Pregnant or breastfeeding women; requirement to use effective contraception during and after study participation with negative pregnancy test for females of childbearing potential
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 screening and enrollment visit
Duration - Approximately 1 week including chemotherapy and CAR T-cell infusions
Participants undergo lymphodepletion chemotherapy followed by sequential infusions of CD146-targeted and HER2-targeted CAR T cells to treat advanced sarcomas.
1 to 3 visits including chemotherapy and CAR T-cell infusion days
Duration - Up to 36 months after CAR T-cell administration
Participants are monitored closely for acute toxicities and treatment response. Follow-up includes physical exams, lab tests, and imaging to assess safety and effectiveness of the CAR T-cell therapy.
Regular visits every 8 to 12 weeks for assessments
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
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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