Actively Recruiting
A Clinical Study of CHT102 Universal Chimeric Antigen Receptor T-Cell Immunotherapy for Mesothelin Positive Advanced Solid Tumors: Single-Arm, Open-Label, Dose Escalation and Expansion Study
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2024-12-04
24
Participants Needed
1
Research Sites
673 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
Researchers are evaluating the safety and effectiveness of CHT102, a universal chimeric antigen receptor T-cell immunotherapy (U CAR-T), in treating patients with mesothelin-positive advanced solid tumors. This study focuses on patients with advanced or metastatic solid tumors that express mesothelin and have not responded to standard first-line therapies or have no recommended first-line treatment options. The trial is sponsored by Tianjin Medical University Cancer Institute and Hospital and aims to assess dose-related toxicities and treatment responses. The study includes a dose escalation phase where participants receive CHT102 allogeneic CAR T cells through multiple infusions. Treatment involves three transfusions of UCAR-T cells on days 1, 5, and 9 within a 28-day cycle. Different dose levels are tested, ranging from 2.5 x 10^6/kg to 3 x 10^7/kg of CAR-positive T cells per infusion, with dose increases between groups. This dose escalation helps determine the appropriate dosage for further evaluation. Participants will be closely monitored for safety, including the occurrence of dose-limiting toxicities up to 28 days after infusion. Researchers will also measure objective tumor response at 4 weeks and overall, as well as progression-free survival up to 6 months. The study involves regular assessments of organ function, tumor measurements by RECIST criteria, and evaluation of patient health status. Participants are expected to remain in the study for follow-up assessments as scheduled to evaluate treatment effects and safety.
CONDITIONS
Brief 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 not responding to standard first-line therapy or without recommended first-line therapy
- Tumor positive for mesothelin expression confirmed by histology or pathology
- At least one measurable lesion at baseline per RECIST 1.1
- Expected survival time greater 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, with some exceptions
- Agreement to use effective contraception for 6 months after CAR-T infusion excluding rhythm contraception
You will not qualify if you...
- Received experimental drug treatment or devices within 28 days
- Received chemotherapy or targeted therapy within 4 weeks
- Received cell therapy products other than mesothelin targets within 1 month
- Positive test for replication competent retrovirus if previously treated with other cell therapies
- Received chemotherapy other than lymphocyte clearance within 14 days prior to infusion
- Received systemic corticosteroids over 10 mg/day prednisone equivalent within 2 weeks
- Received anticoagulant therapy within 7 days prior to infusion
- Prior organ or stem cell transplantation
- Immune deficiency, autoimmune diseases, or requiring immunosuppressants
- Vaccination within 14 days before enrollment or live vaccines during study
- Active or symptomatic brain or meningeal metastases unless stable after treatment
- Serious or uncontrolled systemic diseases including heart failure, recent myocardial infarction, significant arrhythmias, or reduced heart function
- Pregnant, lactating, or breastfeeding females
- Poor control of thoracoabdominal water
- Any condition deemed inappropriate by investigators for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive CHT102 allogeneic CAR T cell infusions on Day 1, Day 5, and Day 9 with dose escalation groups. Each treatment cycle lasts 28 days.
3 infusion visits (in-person) on Days 1, 5, and 9
Duration - Up to 6 months
Participants are monitored for safety and treatment response up to 6 months after the CAR T cell infusions.
Visits at 4 weeks and regular assessments up to 6 months
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
Frequently Asked Questions
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