Actively Recruiting
Pan-T Booster Co-expressing MSLN CAR T Cell Therapy in Advanced/Metastatic Solid Tumors
Led by Chinese PLA General Hospital · Updated on 2024-05-10
15
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
Sponsors
C
Chinese PLA General Hospital
Lead Sponsor
U
UTC Therapeutics Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
In preclinical study, investigators have demonstrated that the newly developed pan-T booster (harbouring CD40 agonist and one T cell costimulator agonist) co-expressing MSLN CAR T cell possess more powerful antitumor activity than previously reported MSLN-CAR T cells. In this clinical trial, enrolled patients receive an initial dose of pan-T booster co-expressing MSLN CAR T cells at 1×10\^6 cells/kg based on the basic principle of dose escalation design, in order to evaluate the safety, feasibility, pharmacokinetics/pharmacodynamics, and efficacy of pan-T booster co-expressing MSLN CAR T cell in vivo.
CONDITIONS
Official Title
Pan-T Booster Co-expressing MSLN CAR T Cell Therapy in Advanced/Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75 years with estimated life expectancy greater than 3 months
- Histopathologically confirmed advanced or metastatic solid tumors that have failed at least first-line treatment or have no recommended first-line therapy, with mesothelin antigen expression of 10% or higher
- At least one measurable target lesion
- Availability of fresh or archival tumor samples within 6 months; willingness to accept tumor rebiopsy during the study
- Previous treatments completed more than 4 weeks prior with recovery to grade 1 or less toxicity
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at enrollment
- Adequate organ function confirmed within 2 weeks before first study drug dose
- Prior treatment with anti-PD-1/PD-L1 antibodies allowed
- Ability to understand and sign informed consent
- Women of child-bearing potential agree to use effective contraception before and up to 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 with no symptoms and off corticosteroids for at least 3 months
- Treatment with corticosteroids (more than 10 mg prednisone daily equivalent) or other immunosuppressive drugs within 14 days before enrollment
- History of severe hypersensitivity to monoclonal antibodies
- Allergy or intolerance to study drug components
- Substance abuse or medical, psychological, or social conditions interfering with study participation or evaluation
- History or presence of interstitial lung disease or severely impaired lung function
- Uncontrolled illness including infection, heart failure, unstable angina, arrhythmias (except mild sinus bradycardia or tachycardia), psychiatric illness, or social situations limiting compliance or safety
- HIV infection or AIDS
- Pregnant or breastfeeding women; negative pregnancy test required within 7 days before enrollment
- Previous or concurrent cancer within 3 years except certain treated cancers
- Vaccination within 30 days before enrollment
- Active bleeding or known bleeding disorders
- Unhealed surgical wounds older than 30 days
- Participation in other trials or withdrawal from trials within 4 weeks
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, 100853
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
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here