Actively Recruiting
HER2 Targeted HypoSti.CAR-T Cells in HER2 Positive Advanced Solid Tumors
Led by Chinese PLA General Hospital · Updated on 2023-12-12
30
Participants Needed
1
Research Sites
168 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
F
Fudan University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chimeric antigen receptor modified T (CAR-T) cell therapy still has multiple difficulties in solid tumors, such as absence of tumor specific antigens, complex immunosuppressive tumor microenvironment, and tumor heterogeneity. In this study, investigators developed a novel hypoxia-stimulated CAR expression system (HypoSti.CAR) that could enable CAR-T cell effectively expand and survive in hypoxic tumor microenvironment. After accomplishment of animal model verification, investigators conduct this clinical trial in order to assess the in vivo safety, feasibility and efficacy of HypoSti.CAR-HER2 T cells in HER2 antigen positive advanced solid tumors.
CONDITIONS
Official Title
HER2 Targeted HypoSti.CAR-T Cells in HER2 Positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75 years with estimated life expectancy over 3 months
- Histopathologically confirmed advanced or metastatic solid tumors with HER2 antigen expression of 30% or higher
- Tumors failed at least first-line treatment or have no standard first-line therapy according to guidelines
- At least one measurable target lesion
- Fresh or recent tumor samples available for biopsy (within 6 months); willing to accept tumor rebiopsy during study
- Completed previous treatments more than 4 weeks prior and recovered to grade 1 or less toxicity
- Eastern Cooperative Oncology Group performance status of 0 to 2 at enrollment
- Adequate organ function confirmed within 2 weeks prior to first dose
- Prior treatment with anti-PD-1/PD-L1 antibodies allowed
- Ability to understand and sign informed consent
- Women of childbearing potential agree to use effective contraception before and for 90 days after last drug dose
You will not qualify if you...
- Active, known or suspected autoimmune diseases
- Known brain metastases or active central nervous system involvement, except treated CNS metastases without symptoms and off corticosteroids for at least 3 months
- Use of corticosteroids (>10 mg prednisone daily equivalent) or other immunosuppressive drugs within 14 days before enrollment
- History of severe allergic reactions to monoclonal antibodies
- Allergy or intolerance to study drug components
- Substance abuse or medical, psychological, or social conditions interfering with study participation
- History or current interstitial lung disease or severely impaired lung function
- Uncontrolled illnesses like active infections, symptomatic heart failure, unstable angina, cardiac arrhythmias (except minor types), or psychiatric/social issues
- History of HIV infection or AIDS
- Pregnancy or breastfeeding; negative pregnancy test required within 7 days before enrollment
- Previous or current cancers within 3 years, except certain treated non-invasive cancers
- Vaccination within 30 days before enrollment
- Active bleeding or known bleeding disorders
- Unhealed surgical wounds over 30 days
- Participation in other clinical trials or withdrawal within 4 weeks prior to enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Kaichao Feng
Beijing, Beijing Municipality, China, +86100853
Actively Recruiting
Research Team
K
Kaichao Feng, MD
CONTACT
W
Weidong Han, 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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