Actively Recruiting
A Clinical Study of CHT102 in Mesothelin Positive Advanced Solid Tumors
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-12-04
24
Participants Needed
1
Research Sites
781 weeks
Total Duration
On this page
Sponsors
T
Tianjin Medical University Cancer Institute and Hospital
Lead Sponsor
N
Nanjing Calmhome Cell and Gene Engineering Institute Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Objectives of Study：In this study investigators plan to evaluate the safety and efficacy of MSLN-targeting Universal Chimeric Antigen Receptor T-Cell Immunotherapy(U CAR-T) in the treatment of MSLN-positive advanced solid tumors.
CONDITIONS
Official Title
A Clinical Study of CHT102 in Mesothelin Positive Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign a written informed consent document
- Age 18 years or older, male or female
- Histopathologically confirmed advanced or metastatic solid tumors that have failed at least standard first-line therapy or have no recommended standard first-line therapy
- Tumor tissue confirmed positive for mesothelin expression (IHC 2+)
- At least one measurable tumor lesion at baseline according to RECIST version 1.1
- Expected survival time of more than 12 weeks
- ECOG performance status of 0 or 1
- Basically normal function of important organs
- Recovery from previous treatment toxicity to grade 1 or less, except certain specified conditions
- Agreement to use reliable and effective contraception for 6 months after CAR-T infusion (excluding rhythm contraception)
You will not qualify if you...
- Received any experimental drugs or devices within 28 days
- Received chemotherapy or targeted therapy within 4 weeks
- Received cell therapy products other than mesothelin-targeted within 1 month
- Positive test for replication competent retrovirus if previously received other cell therapy
- Received chemotherapy other than lymphocyte clearance chemotherapy within 14 days prior to infusion
- Systemic corticosteroid therapy above 10 mg/day prednisone equivalent within 2 weeks
- Use of oral or intravenous anticoagulants within 7 days prior to infusion
- History of organ allograft or allogeneic hematopoietic stem cell transplantation
- Immune deficiency, autoimmune diseases, or need for immunosuppressants
- Vaccination within 14 days before enrollment or live vaccine during study
- Active or symptomatic central nervous system metastases or meningeal metastases
- Serious or uncontrolled systemic diseases including uncontrolled hypertension, hyperglycemia, liver or kidney insufficiency, or central nervous system disease
- Certain heart conditions including severe heart failure, recent myocardial infarction or bypass surgery, significant arrhythmias, or low cardiac ejection fraction
- Pregnant, lactating, or breastfeeding females
- Poor control of thoracoabdominal water
- Other conditions deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
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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