Actively Recruiting
A Single-Arm, Open-Label, Phase I Study of CHT102 for MSLN-Positive Advanced Pancreatic Cancer
Led by Tianjin Medical University Cancer Institute and Hospital · Updated on 2025-04-10
21
Participants Needed
1
Research Sites
626 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
This research aims to evaluate the safety and effectiveness of mesothelin-targeting UCAR-T cells called CHT102 in adults with mesothelin-positive advanced pancreatic cancer who have not responded to or cannot tolerate standard treatments. It is a phase 1, open-label study conducted by Tianjin Medical University Cancer Institute and Hospital to better understand this treatment's potential in this serious condition. Participants will receive CHT102 through arterial infusion. The study includes a dose escalation phase with three planned dose groups, followed by a dose expansion phase after a safety review committee evaluates available safety, pharmacokinetics, and preliminary efficacy data. This single-arm study does not include a placebo or comparator group. Throughout the study, participants will be closely monitored for safety and tolerability over two years. Researchers will assess tumor response using measures such as objective response rate and disease control rate at four weeks and overall, progression-free survival over two years, and overall survival over three years. Pharmacokinetics and pharmacodynamics will be evaluated for six months to understand how the treatment behaves in the body. The total duration of participant involvement will span several years to carefully track outcomes and safety.
CONDITIONS
Brief Title
A Clinical Study of CHT102 in MSLN-Positive Advanced Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign a written informed consent document
- Age between 18 and 70 years, male or female
- Histopathologically confirmed advanced or metastatic pancreatic cancer
- Failed to standard treatment or intolerance with standard treatment
- Positive mesothelin expression
- At least one measurable lesion at baseline per RECIST version 1.1
- Expected survival time of more than 12 weeks
- ECOG performance status 0-1
- Adequate organ functions
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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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 - Up to 2 years
Participants receive CHT102 by arterial infusion as part of the dose escalation and expansion phases to evaluate safety, pharmacokinetics, and preliminary efficacy.
Visits occur according to dosing and safety assessment schedules during treatment
Duration - Up to 3 years
Participants are monitored for safety and survival outcomes after treatment ends, including assessments of overall survival and progression-free survival.
Follow-up visits scheduled periodically up to 3 years post-treatment
Trial Site Locations
Total: 1 location
1
Tianjin Medical University Cancer Institute & Hospital
Tianjin, China
Actively Recruiting
Research Team
J
Jihui Hao, Ph.D
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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