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New treatment option for Mesothelin Positive Tumors
Official title A Clinical Study of CHT102 in Mesothelin Positive Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06717022
What this study is testing
What is CHT102 allogeneic CAR T cells?
CHT102 allogeneic CAR T cells is an investigational medicine, being studied as a potential treatment for mesothelin positive tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Ability to understand and sign a written informed consent document；
- Age ≥18 years old, male or female；
- Histopathological confirmed advanced or metastatic solid tumors failed to at least standard first-line therapy or initially diagnosed advanced solid...
- Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor MSLN...
- At least one measurable lesion at baseline per RECIST version 1.1；
You likely can't join if
- Received any experimental drug treatment or used experimental devices within 28 days;
- Received anti-tumor therapy such as chemotherapy and targeted therapy within 4 weeks;
- Received cell therapy products other than MSLN targets within 1 month;
- Patients who have previously received other cell therapy products should be tested for RCL(Replication Competent Retrovirus ) during the screening...
- Received chemotherapy other than lymphocyte clearance chemotherapy within 14 days prior to CHT102 infusion;
- Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks；
See the full eligibility criteria
- Ability to understand and sign a written informed consent document；
- Age ≥18 years old, male or female；
- Histopathological confirmed advanced or metastatic solid tumors failed to at least standard first-line therapy or initially diagnosed advanced solid tumors that have no National Comprehensive Cancer Network (NCCN...
- Histopathology or cytology (paraffin section or fresh biopsy tumor tissue specimen) diagnosed as advanced/metastatic solid tumor (positive tumor MSLN expression (tumor MSLN positive (IHC 2+) confirmed by histology or...
- At least one measurable lesion at baseline per RECIST version 1.1；
- The expected survival time is more than 12 weeks;
- ECOG(American Eastern Oncology Consortium) 0-1 points;
- The function of important organs is basically normal;
- The investigator determines that the patient must have fully recovered from previous treatment toxicity to ≤ grade 1, except in the following cases: a. Hair loss; b. Pigmentation; c. Long-term toxicity caused by...
- people agree to use reliable and effective contraceptive methods for contraception within
- 6 months after signing the informed consent form to receiving CAR-T cell infusion (excluding rhythm contraception).
- Received any experimental drug treatment or used experimental devices within 28 days;
- Received anti-tumor therapy such as chemotherapy and targeted therapy within 4 weeks;
- Received cell therapy products other than MSLN targets within 1 month;
- Patients who have previously received other cell therapy products should be tested for RCL(Replication Competent Retrovirus ) during the screening period if any test result is positive;
- Received chemotherapy other than lymphocyte clearance chemotherapy within 14 days prior to CHT102 infusion;
- Received systemic corticosteroid therapy at doses greater than 10 mg/day prednisone (or equivalent doses of other corticosteroids) within 2 weeks；
- Patients receiving oral or intravenous anticoagulant therapy within 7 days prior to CHT102 cell infusion;
- Prior organ allograft transplantations or allogeneic hematopoietic stem cell transplantation;
- Patients with immune deficiency or autoimmune diseases, or who require immunosuppressants;
- Vaccination within 14 days of study enrollment, or who required live vaccine immunization during the study period;
- Active/symptomatic central nervous system metastases or meningeal metastases at the time of screening; people with brain metastases who have been treated must be confirmed to have no imaging evidence of progression ≥ 4...
- Serious or uncontrollable systemic disease or any unstable systemic disease, including but not limited to uncontrolled hypertension, uncontrolled hyperglycemia, liver and kidney insufficiency or metabolic disease...
- Have any of the following heart conditions:
- New York Heart Association (NYHA) stage III or IV congestive heart failure;
- Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months before enrollment;
- Clinically significant ventricular arrhythmia,
- echocardiography showed cardiac ejection fraction\ 450 ms，QTc (female)\>470 ms；;
- Pregnant, lactating, or breastfeeding females;
- Patients with poor control of thoracoabdominal water;
- Other investigators deem it inappropriate to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.