NCT06760364RecruitingPhase 1
A Single-Arm, Open-Label, Phase I Study of CHT102 for MSLN-Positive Advanced Pancreatic Cancer
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country21 target enrollmentStarted: December 25, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability
Study Overview
Brief Summary
Evaluate the safety and efficacy of mesothelin-targeting UCAR-T cells in the treatment of mesothelin-positive advanced pancreatic cancer
Detailed Description
3 planned dose cohorts will be evaluated during dose escalation phase. The dose expansion will be initiated after SRC (safety review committee) review the avaliable safety, PK and preliminary efficacy data.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability to understand and sign a written informed consent documen；
- •At the date of signing ICF, 18 ~70 years old, male or female；
- •Histopathological confirmed advanced or metastatic pancreatic cancer patients who have failed to standard treatment or intolerance with standard treatment；
- •Positive mesothelin expression;
- •At least one measurable lesion at baseline per RECIST version 1.1；
- •The expected survival time is more than 12 weeks;
- •ECOG 0-1 points;
- •Adequate organ functions.
Exclusion Criteria
- Not provided
Arms & Interventions
CHT102 infusion
Experimental
CHT102 will be dosing by arterial infusion.
Intervention: CHT102 (Drug)
Outcomes
Primary Outcomes
Safety and Tolerability
Time Frame: 2 years
Treatment-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
Secondary Outcomes
- pharmacokinetics (PK)(6 months)
- PD(6 months)
- Progress-free survival(PFS)(2 years)
- Disease control rate (DCR)(At 4 weeks, and overall)
- Objective response rate (ORR)(At 4 weeks, and overall)
- Overall survival (OS )(3 years)
Investigators
Study Sites (1)
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