A PD-L1-targeting chimeric switch receptor enhances efficacy of CAR-T cell for pleural and peritoneal metastasis.
Qizhi Ma, Xia He, Benxia Zhang...
https://pubmed.ncbi.nlm.nih.gov/36402752Actively Recruiting
Early Phase 1
Age: 18Years - 75Years
All Genders
ID04684459
Phase I Study of Dual-targeting HER2 and PD-L1 CAR-T Cell Therapy for HER2-positive Solid Tumors
Led by Sichuan University · Updated on 2024-10-30
18
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying a new dual-targeting CAR-T cell therapy for patients with HER2-positive solid tumors, including breast, ovarian, lung, gastric, and other cancers. This early-phase trial aims to enhance the ability of CAR-T cells to fight tumors by transforming an inhibitory signal into an activation signal in the tumor environment. The study focuses on evaluating safety and side effects, as well as initial effectiveness in controlling tumor growth.
CONDITIONS
Brief Title
Dual-targeting HER2 and PD-L1 CAR-T for Solid Tumors
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female, aged 18 to 75 years; subjects over 75 may be enrolled based on health condition
- Estimated life expectancy of at least 3 months
- ECOG performance status score of 0 to 2
- Diagnosed with specified cancers including ovarian, non-small cell lung, breast, gastric, head and neck, pancreatic, colorectal, transitional cell carcinoma, endometrial carcinoma, sarcoma, glioblastoma, and cholangiocarcinoma
- HER2 expression greater than 20% in tumors or metastatic cells by IHC or FISH
- Adequate blood counts: neutrophils, platelets, lymphocytes, hemoglobin
- Kidney and liver function within specified limits
- Cardiac ejection fraction of 50% or above without pericardial effusion
- No serious autoimmune or immune deficiency diseases
- Stopped chemotherapy and targeted therapy at least 3 weeks before treatment
- Use of reliable contraception before and for 1 year after CAR-T infusion
- Voluntary participation with informed consent
- Side effects of last anti-tumor treatment reduced to grade 1 or less except hair loss
You will not qualify if you...
- Allergy to cytokines
- Active uncontrolled infection
- Acute or chronic graft-versus-host disease
- Presence of other uncontrolled malignant tumors
- Active hepatitis B or C, or HIV infection above normal limits
- Serious heart or brain diseases including coronary disease, arrhythmia, stroke
- Grade 2-3 or poorly controlled hypertension
- Difficult-to-control mental illness
- Long-term use of immunosuppressive agents after organ transplant except inhaled corticosteroids
- Medical or mental conditions increasing risk of study participation
- Recent unstable blood clots or thromboembolic events within 6 months
- Pregnant or nursing, or planning pregnancy during treatment or within 1 year after
- Unable or unwilling to comply with study procedures or consent requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 12 months
Participants receive dual-targeting HER2 and PD-L1 CAR-T cell therapy through serosal cavity infusion for HER2-positive solid tumors.
Visits as needed for infusion and monitoring during treatment period
Follow-up
Duration - Up to 12 months
Participants are monitored for treatment-related adverse events, dose-limiting toxicity, and response to therapy for up to 12 months after treatment.
Visits at Month 1, Month 3, Month 6, and additional visits as needed
Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
Loading map...
Research Team
Q
Qizhi Ma, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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