Actively Recruiting
U87 CAR-T in Patients With Advanced Head and Neck Tumors
Led by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd · Updated on 2024-09-26
20
Participants Needed
1
Research Sites
171 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-arm, open-label clinical study to evaluate the safety, tolerability, and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors.
CONDITIONS
Official Title
U87 CAR-T in Patients With Advanced Head and Neck Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent and willing to complete study procedures
- Aged 18 to 70 years at consent, any gender
- ECOG performance status of 0 to 1
- Expected survival of at least 12 weeks
- Histologically or cytologically confirmed advanced malignant head and neck cancer with no effective standard treatments
- Positive Trop2 expression (intensity 2+, expression rate 40%) in tumor tissue within 2 years or recent biopsy
- At least one measurable tumor lesion by RECIST 1.1
- Suitable venous access for mononuclear cell collection
- Adequate major organ function
- Negative pregnancy test for women of reproductive age; agreement to use effective contraception during study and for 1 year after last CAR-T infusion
You will not qualify if you...
- Insufficient washout from prior anti-cancer treatments before leukapheresis
- Live or attenuated vaccine within 4 weeks before leukapheresis or planned during study
- Major surgery or significant trauma within 4 weeks before leukapheresis or planned during study
- Prior Trop2-targeted CAR-T, TCR-T, other cellular therapies, or therapeutic cancer vaccines
- Symptomatic brain or leptomeningeal metastases deemed ineligible
- Active infection requiring intravenous anti-infective therapy
- Positive tests for HBsAg, HBeAg, HBV-DNA, HCV antibodies or RNA, TP antibodies, HIV antibodies, elevated EBV-DNA or CMV-DNA
- Primary immunodeficiency or active autoimmune disease
- Chronic systemic corticosteroids or immunosuppressants use within 7 days before leukapheresis (except local or inhaled forms)
- Unresolved adverse effects of prior treatments above specified severity
- History of interstitial lung disease, pneumonia, pulmonary inflammation, or extensive thoracic radiotherapy
- Allergy to protein drugs or multiple medications
- Other untreated malignancies within 5 years, history of immune deficiency, stem cell/organ transplant, or uncontrollable fluid accumulation
- Severe cardiovascular or cerebrovascular disease including NYHA class II or higher heart failure, uncontrolled hypertension, or recent severe events
- Pregnant or breastfeeding women
- Uncontrollable psychiatric history
- Other conditions judged unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Eye ENT Hospital of Fudan University
Shanghai, China, 200000
Actively Recruiting
Research Team
H
Haitao Wu, Ph.D
CONTACT
J
Jian Chen, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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